Clinical Research Nurse Resume Samples

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M Wintheiser

Mossie

Wintheiser

8555 Destini Extension

Chicago

+1 (555) 257 4953

8555 Destini Extension

Chicago

Phone

p +1 (555) 257 4953

Experience Experience

New York, NY

Clinical Research Nurse

New York, NY

Crist, Rowe and Denesik

New York, NY

Clinical Research Nurse

RN license
Becomes familiar with all protocols assigned. For assigned studies, initiates study start-up activities including study initiation meeting, scheduling subject visits, along with scheduling any outside personnel or tests for these individual visits
Access and extract information for protocol development for investigator-initiated trials. Summarize literature review for study hypothesis
Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Carry out the informed consent process and enroll subjects. Ensure completion of study procedures per protocol
Extract data from source documents. Complete Case Report Forms (CRF) or database entries
Trains staff
Further Particulars

Dallas, TX

Clinical Research Nurse, RN

Dallas, TX

Turcotte LLC

Dallas, TX

Clinical Research Nurse, RN

Assisting with all regulatory document preparation and submissions, including documentation for the FDA
The individual recruited for this position will be actively involved in all aspects of the Sickle Cell Disease Program. Although the conduct of sickle cell-related clinical trials will be the primary responsibility, at the discretion of the Program Director, this individual will be a full participant in the clinical program and will be involved in many aspects of patient care
Assists in identifying, reporting and following up on Serious Adverse Events
Traveling to national meetings as deemed beneficial to the research
Functioning as a resource for the medical staff, patient/family and community, providing educational information and expertise in the area of sickle cell disease research
Performs clinical data gathering and measurements; maintains study databases; compiles and analyses data retrieved from ongoing clinical trials
Coordinates monitoring activities; completes case report forms; responds to sponsor queries, prepares for audits, IRB and/or the FDA/DHHS

present

Dallas, TX

Clinical Research Nurse Coordinator

Dallas, TX

Lebsack, Murphy and Rosenbaum

present

Dallas, TX

Clinical Research Nurse Coordinator

present

Develops, establishes and maintains productive relationships with VCU colleagues, all customers and contacts at affiliate sites to achieve essential research outcomes. Meets directly with patients at their locations
Ambulatory Medication Administration, Adult Medication
Other: trials in this group are complex and so nursing knowledge to assesss AEs and comprehend I/E are necessary
Ambulatory Medication Administration, Adult Medication, , OR Medication, Blood Administration (Adult/Peds), Peripheral IV Insertion and Maintenance, Alaris Pump Set up and Use, Draw blood from arterial lines, , , , , , , ,
Coordinates and designs systems to collect data, supervises data managers and interfaces with agencies and groups related to the research process
Adhere to an IRB approved protocol
Coordinate protocol related research procedures, study visits, and follow-up care

Education Education

Bachelor’s Degree in Nursing

Washington State University

Bachelor’s Degree in Nursing

Skills Skills

Knowledgeable about standards of nursing practices
Good handwriting and attention to detail
Ability to comprehend professional and scientific journals
Ability to pay close attention to detail
Familiarity with research process is highly desirable
Collaboration. Collaborates with other healthcare professionals to provide efficient quality patient care
Working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet knowledge skills
Working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet knowledge and skills
Strong clinical skills and knowledge
Have the ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

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Clinical Research Nurse Resume Examples & Samples

5 years of clinical research nursing experience
Academic leader recognized for scholarship in research nursing
Proficient in grant and scholarly writing
Expertise and mentoring in the areas of human subject protection and the development of research protocols $

Clinical Research Nurse Resume Examples & Samples

Associate's Degree in Nursing and/or Bachelor's degree in a health related field
1+ year of clinical research experience
Proficiency in Microsoft Office programs
Certification in the Protection of Human Research Subjects
Demonstrated research skills
Prior Oncology experience

Clinical Research Nurse Resume Examples & Samples

Provides direct patient care involving diagnosis, administration of medications, and performance of tests under the direction of the principal investigator or supervising physician; Provides health practices information and education to patients regarding medications, diseases, and any special procedures; Acts as a liaison for patient/physician telephone calls
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in nursing from an accredited nursing program; OR appropriate combination of education and experience
10 years+ experience in clinical research or academic medical center environment
Proven clinical assessment skills
ACRP Membership

Clinical Research Nurse Resume Examples & Samples

Recruits, interviews, and obtains informed consent from prospective subjects for entrance into clinical trials and studies regardless of the funding sources
Coordinates appropriate laboratory tests and other procedures for subjects participating in studies including drawing blood or collection of other samples
Coordinates with the Carolinas Medical Center Investigation Drug Services Department for subjects to receive required drugs
Performs case management for subjects enrolled in studies and is responsible for communicating with Carolinas Medical Center Accounting and/or Research Finance for proper management of patient billing
Coordinates and submits appropriate documents and reports to the Institutional Review Board and to Research Data Manager of the department
Records all appropriate clinical and laboratory data on forms provided by the principal investigator(s), federal government, and/or industry sponsors
Attends clinics and makes hospital rounds on subjects enrolled in studies
Travels to local area hospitals, physician offices, and daycare facilities to obtain follow-up information on subjects being treated away from Carolinas Medical Center. May also need to recruit subjects at off-site Clinics
Communicates with study sponsors, federal agencies, principal investigators, and co-investigators about research projects
Supervises student researchers and research assistants

Clinical Research Nurse Resume Examples & Samples

Current State license as a registered nurse (RN)
A minimum of one (1) year of nursing and/or related clinical research experience
Experience with adult patient populations
Prior research nurse experience with clinical trials in an outpatient setting
Data management and collection experience
Ability to capture and analyze patient data including toxicity assessment, drug administration, laboratory results and tumor response
Knowledge of clinical data report preparation
Knowledge of basic behavioral science and counseling theory and principles
Knowledge of clinical research protocol design, development, interpretation, implementation and evaluation
Knowledge of the research process, including problem identification, literature review, proposing hypothesis, research data collection, statistical analysis of data and the recommendation of findings
Ability to apply knowledge to the clinical care of cancer patients
Ability to provide emotional support in helping patients cope with stress associated with cancer

Clinical Research Nurse Resume Examples & Samples

Providing direct patient care involving diagnosis, administration of medications, and performance of tests under the direction of the principal investigator or supervising physician; Providing health practices information and education to patients regarding medications, diseases, diet, exercise, and any special procedures; Acting as a liaison for patient/physician telephone calls; Assisting patients by providing appropriate referrals to physicians, clinics, or agencies
Successful completion of a full 4-year course of study in nursing from an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience
Proven knowledge of the principles, practices, and techniques of nursing care, health care data management techniques and systems
Clinical Research Coordinator certification

Clinical Research Nurse Coordinator Resume Examples & Samples

Protocol Coordination
Must be a currently license LPN or RN. With 2-3 years of experience, and proven ability to multi-task. Candidate must have some direct research experience
Must be able to work both independently and in a team setting
Must have excellent communication, organization, and prioritization skills
Intermittent physical activity including bending, reaching, and prolonged periods of sitting and or standing
Incumbent may be required to work at any facility and be responsible for own transportation
Incumbent will be scheduled based on operational and business needs
Required Knowledge, Skills and Abilities; knowledge of applicable highly complex scientific procedures and techniques relating to position
Physical Capabilities: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material
Work Environment: laboratory environment; may require working evenings and weekends
Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific/office procedures and techniques relating to position
Must be able to work independently following a brief period of specific technical training
Basic Life Support (BLS –CPR/AED) certification
Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) preferred, or commitment to sit for exam during first year of employment

Clinical Research Nurse Resume Examples & Samples

Access and extract information for protocol development for investigator-initiated trials. Summarize literature review for study hypothesis
Participate in protocol development or review of risk assessment. Evaluate the protocol, study design and risk to subject population. Determine staff, facility, and equipment availability. Assess study population/availability
Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Carry out the informed consent process and enroll subjects. Ensure completion of study procedures per protocol
Extract data from source documents. Complete Case Report Forms (CRF) or database entries

Clinical Research Nurse Resume Examples & Samples

Registered nursing qualification (NMC registered) is essential (Degree qualification in Nursing or a Life Science is preferred)
Having an excellent organizational ability and written and oral communication skills
Demonstrating an aptitude for paperwork and knowledge of Microsoft Office with keen attention to detail
Setting very high standards for your own performance and be an exceptional team player
Showing a flexible attitude with respect to work assignments, new learnings and willingness to work night shifts

Clinical Research Nurse Resume Examples & Samples

Demonstrated leadership ability and critical thinking
Ability to assess, monitor and respond to emergency situation
Excellent interpersonal, verbal and written communication skills
Demonstrated competency in all research-related tasks
Preferably 1 year of clinical experience in an acute hospital setting or comparable experience in a clinical research environment

Clinical Research Nurse Coordinator Resume Examples & Samples

Coordinate research activities and direct patient care of assigned IRB approved protocols such as physical assessments, vital signs, assessing specific signs and symptoms, and drawing blood (if applicable)
Work with the PI to develop and implement recruitment strategies in accordance with IRB/HRPO requirements and approvals
Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design
Ensure the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented
Observe universal precautions and OSHA standards when processing or handling specimens
Collect data in a timely and accurate manner and submit information to coordinating centers as required
Maintain detailed documentation of the research study including but not limited to subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder
Attend conferences and other meetings as required by the protocol, the PI, or sponsoring agency
Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons
Maintain patient confidentiality according to HIPAA and institutional regulations
Assist principal investigators, research team members, and other staff in the development of, preparation for, and closeout of clinical research studies
A minimum of two years’ experience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
Ability to communicate effectively in written and oral modes and to teach in formal and informal settings
Good typing skills to allow online documentation of patient interactions
Complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and integrity training within one month from start date

Clinical Research Nurse Resume Examples & Samples

Demonstrate attention to detail
Be self-directed and able to work with minimal supervision
Ability to provide emergency care
Comprehensive assessment skills
Provide client and trial participant focused approach to work
Flexible attitude with respect to work assignments and new challenges
Manage multiple and competing priorities and varied tasks with enthusiasm and prioritize workload
Excellent management skills
Willingness to work in a complex environment and to value the importance of teamwork
Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail
Minimum Work Experience: At least 3 year related experience
Familiarity with research process is highly desirable

Clinical Research Nurse Resume Examples & Samples

Manage the CHND and other databases used for quality improvement and clinical research. The databases are populated with data extracted by the incumbent from clinical records through chart review and data forms. These databases are used for outcomes assessment of patient populations managed in the Riley neonatal intensive care unit and compared to aggregate data from other neonatal intensive care units within Indiana and the United States. Data accuracy assessment, summary data reports, data sharing with the Indiana University Health Electronic Data Warehouse and database updates will be developed and facilitated in collaboration with the physician leadership
Participate in development, review and evaluation of study contracts and agreements including identifying resources needed to conduct and evaluate study procedures and data. Assess study population and availability. Develop and manage recruitment strategies including but not limited to subject identification, distribution of informational materials for recruitment and consent and enrollment. Organize and distribute regulatory documents. Provide for security of study source documentation tools and subject’s chart/records. Train study team members on technical aspects of study trials including but not limited to data collection, conducting surveys, interviewing subjects, specimen collection and processing. Communicate with PI and other team members about any changes in study protocols, study procedures and/or data collection. Communicate and interact with the public, potential subjects, study subjects, medical staff and other team members in a respectful, truthful and clear manner
Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria; Identify, schedule screening procedures and review results; Recruit subjects and keep accurate records; Obtain patient consent including discussion of treatment/intervention alternatives and signature on Informed Consent forms; Determine appointments with parents, study subjects, families, and medical staff per protocol; Serve as an advocate for the subjects and their family; Prepare for monitor visits; record, document and report protocol deviations; Facilitate and participate in pre-study visits with sponsor
Extract data from source documents and complete Case Report Forms (CRF) or database entries; Order and receive drug/device supplies as directed; Capture and record adverse event data; Manage handling and processing of laboratory specimens; Maintaining sample/specimen tracking and inventory; Order and receive drug/device supplies; Prepare and present study protocol reviews at monthly meetings; Review on-going study subjects on a daily basis
Aid with administrative duties for the clinical program including but not limited to; entering study data into study databases, filing, photocopying, arranging meetings, and data entry; Work in a team environment with a professional and positive attitude; Attend, present and reside over weekly informative conferences to better understand signs/symptoms and diagnosis for current patients; Able and willingness to take call when needed as a shared responsibility within the team

Clinical Research Nurse Resume Examples & Samples

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience
At least 3 years’ previous working experience in research/clinical trials and/or HIV/AIDS or related specialty
Analysis

Clinical Research Nurse Resume Examples & Samples

Clinical research experience preferred but can train nurse who has 5+ years of clinical experience working directly with patients as a nurse
Excellent, professional written and verbal communication skills required
This position involves a great deal of computer systems knowledge for data entry of clinical information and responding to queries about data entered. Must have strong computer skills with EMR or other medical systems experience
Research certification preferred
Knowledge of medical practice operations
Work requires interpersonal skills necessary to function as liaison between physicians, office staff and the patients and their family members. Must be able to handle a fast-paced environment in a confident, professional manner
Must be a self- motivator, possessing a high level of judgment skills and initiative, along with ability to prioritize and coordinate several tasks simultaneously, while retaining a confident, knowledgeable and helpful demeanor
Ability to listen compassionately, demonstrating effective problem-solving and critical-thinking techniques to areas of concern to patients and employees, without appearing judgmental is essential

Clinical Research Nurse Resume Examples & Samples

NICU, PICU or control care experience
Research experience a plus
Strong interpersonal and communication skills are required for this position that requires interaction with new mothers, hospital staff, and study team members

Senior Clinical Research Nurse Resume Examples & Samples

Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP's), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
Oversees and monitors the well-being and safety of study participants by active assessment as well as by serving as a visible point of contact at all times
Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through
Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing
Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment
Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication
Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event
Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction
Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study
In the absence of the Clinical Study Manager, performs as the floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor
Demonstrates professionalism and provides leadership to the various members of the clinical study team
Administers study medication according to study protocol, demonstrates thorough understanding of study medications, and administers concomitant medication as directed by the PI and maintains accurate and timely documentation of the process
Coordinates with the scheduling department to ensure coverage of clinical conduct activities
Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction
One to two (1-2) years of nursing experience in a clinical research environment
One to two (1-2) years in a lead nursing role or nursing supervisory experience
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Possesses leadership skills and abilities
Able to provide excellent customer service, with experience in public relations
Able to communicate professionally and effectively both verbally and in writing with participants from diverse backgrounds

Senior Clinical Research Nurse Resume Examples & Samples

Identifying gaps in clinical nursing training, as well as training on SOPs and processes. Creates and proposes input into development of action plans and supporting with implementation to bring all CRN team members to equivalency in nursing practices or other department needs. Working closely with management, medical director and consultants/others, as required to ensure appropriate support is provided. Develop tools, training curriculums and competency assessments to support thorough knowledge in nursing practices amongst the team
Provides direction to Charge Nurse to ensure duties are performed appropriately
Provides work direction to CRN team to ensure appropriate patient and healthy study participant care and study conduct assignments
Provides work direction to CRN team to ensure responsibility for upholding the protocol, SOPs and GCP in all work processes to ensure efficient and compliant clinical operation within the Early Phase Clinical Unit (EPCU), including but not limited to; daily crash and medication cart checks; recording, monitoring and following up with PI daily on Adverse Events (AE’s); and review, monitoring and following up on concomitant medications, discussing with PI as required
Responsible for providing clinical/protocol related training to ensure understanding across the clinic floor, guiding and directing staff and others to ensure safety and protocol compliance
Responsible for providing CRN team with direction on ensuring study participant safety, identifying and responding to changes in the study participant’s physical, mental, and/or behavior to take appropriate action, and if necessary, notify physician and/or research team, documenting as required
Responsible for providing CRN team with direction with assessment, monitoring, recording, and reporting patient’s condition and reaction to drugs and treatments to the appropriate physician and CRC, and dispensing medication as directed
Responsible for providing CRN team with direction on expectations of dosing nurse for studies and administer IP via any route as per protocol, nurse practice, clarifications and guidelines. Proactively plan and prepare dosing procedures/instructions (for example, preparing the Dosing Information Sheet)
Responsible for providing CRN team with direction on IP chain of custody in coordination with the Pharmacy
Responsible for providing CRN team with direction on administration of concomitant medication (all routes), give treatments and perform other medical procedures as prescribed by the physician (medical group)
Responsible for providing CRN team with direction on assist physician or perform more complex clinical procedures as required
Responsible for providing CRN team with direction on responding, leading and assisting in emergency and code situations by following standard emergency protocols and SOPs
Ensure that all nursing and protocol-related procedures are completed and documented according to GCP and standard nursing practice
Support CRN team on the floor when additional help is needed
Maintain and update professional competencies, ensuring knowledge and understanding of Clinical Operating Guidelines and related hospital policies, as applicable
Amenable to flexible working schedule as required by business and workflow, including shift rotations, weekend and evening work, on-call obligations, as well as an understanding that flexibility in work schedule is important to meet business needs
Act as a mentor to new members of the nursing staff and assist with training, as well as overseeing mentorship process across the CRN group
Provide expertise and feedback on protocol review as well as active participation in study setup, working closely with the Clinical Research Coordinator (CRC)
Works closely with Management to monitor CRN staff performance and proactively assist with developing methods and strategies of performance improvement
Demonstrates exceptional problem solving and critical thinking skills
Able to approach work methodically and prioritize own workload
Can work effectively under pressure and keep to timelines
Sense of urgency and use of initiative, as well as a client focused approach to work
BSN preferred or relevant work experience
Current Advanced Cardiac Life Support (ACLS) required. (within 6 months of hire)
Current Basic Life Support (BLS) required
Preferably 3-5 years plus of clinical experience in an acute hospital setting or comparable experience in a clinical research environment

Clinical Research Nurse Resume Examples & Samples

Recruit participants according to IRB approved methodologies. Using acceptable procedures, review records, identify and screen potential participants to ensure they meet the study criteria. Monitor enrollment goals and modify recruitment strategies as necessary
Ensure appropriate informed consent processes are followed: including discussions of treatment and intervention alternatives, voluntary nature of the study, ongoing opportunity for questions and discussions, understanding of participant, assent when appropriate, and proper documentation of process
Coordination of visits, Schedule participant visits with support services, perform interviews and clinical assessment to collect data required by the protocol. Complete source documents, case report forms, and other paperwork for study visits. Evaluate patient status for safety and ensure optimum health care
Attend and participate in investigator meetings and calls with the sponsors. Review and assess progress and conduct of study design and implementation
Maintain study files, provide copies of forms to study sponsor, IRB, general clinical research center, FDA etc. including reporting of SAEs, AEs per regulatory and institutional guidelines. Act as a liaison between research staff, study sponsor, IRB, federal state and University officials and other regulatory agencies
Order and receive drug/device supplies. Dispense drug (calculate dosage as needed), supplies, and devices according to sponsor directions and institutional procedures. Provide clear instructions to the participants &/or their families
Ensure proper collection, documentation, processing and shipment of specimens
Oversee proper documentation of close-out as required by grant sponsors including return of unused supplies, reconciliation of test/drug accountability forms, study summary, evaluation of team effort and subject enrollment. Prepare and respond to sponsor or FDA audits
Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training and conferences

Clinical Research Nurse Resume Examples & Samples

Providing direct patient care involving diagnosis, administration of medications, and performance of tests under the direction of the principal investigator or supervising physician; Providing health practices information and education to patients regarding medications, diseases, diet, exercise, and any special procedures; Acting as a liaison for patient/physician telephone calls; Assisting patients by providing appropriate referrals to physicians, clinics, or agencies. (30%)
Reviewing medical records; Reviewing clinical and laboratory evaluations; Maintaining appropriate source documentation and appropriately and accurately completing patient charts and/or case reports. (30%)
Evaluating and enrolling patients in clinical research studies; Obtaining patients’ informed-consent, Collecting scientific samples and detailed, accurate data; Arranging follow up medical care to insure ongoing monitoring of patients in research protocols; Reporting adverse events to principal investigator and/or sponsor in a timely manner. (30%)
Preparing materials for submission to the IRB and participating in protocol development by drafting study protocols and/or reviewing potential protocols to evaluate their effect on standard nursing procedures; Preparing financial records including quarterly reports, budget, and subject-related expense; Preparing for and completing close out procedures for terminated studies, ensuring all FDA, sponsor, and University regulations have been followed; Acting as a protocol resource for other research team members; Participating actively in clinical meetings, rounds, and departmental meetings. (5%)
Participating in departmental activities, special projects, and other duties as required or assigned. (5%)
1 to 3 years’ experience in clinical research or academic medical center environment

Clinical Research Nurse Resume Examples & Samples

Manage patient interactions and follow-up including recruitment, consent, and study visits at Methodist Hospital, Eskenazi Health, and VAMC
Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance
Schedule, prepare for and participate in monitor visits. Prepare and respond to Sponsor or FDA audits
Develop solutions to complex problems that impact the timely and accurate conduct of clinical research
Expected to participate in on-call rotation for any studies that require 24/7 enrollment

Clinical Research Nurse Resume Examples & Samples

Screens patients for eligibility for inclusion into the studies; Provide direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects, identification of home care needs
Current license as Registered Professional Nurse in State of Illinois
Striving for excellence with our work processes and outcomes, honoring University policies and regulatory requirements
MSN with oncology specialty
Clinical research experience preferred including administration of

Clinical Research Nurse Resume Examples & Samples

Client focused approach to work
Willingness to work in a matrix environment and to value the importance of teamwork
Able to approach work methodically
Sense of urgency and use of initiative
Work to deadlines
Able to prioritise, delegate and follow through
Self motivated and able to motivate others

Clinical Research Nurse Resume Examples & Samples

NICU, PICU or Critical Care experience
Research experience is a plus
Strong interpersonal and communication skills are required for this position and that involves interaction with new mothers, hospital staff and study team members

Clinical Research Nurse Resume Examples & Samples

Participate in the evaluation of research protocols including study design and risk to target population. Access and extract information for protocol development. Assess target population/availability. Assist in determining staff, facility and equipment availability
Prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor
Schedule study-related meetings and training sessions. Provide instruction to study team for specific study assignments
Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Determine appointments per protocol. Schedule subjects for appointments. Perform subject interviews and assessments at study visits for data required by protocol. Assess and ensure subject safety throughout participation in trial
Extract data from source documents. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Resolve sponsor queries. Provide/create source documentation tools for subject’s charts/records
Order and receive drug/device supplies. Dispense drug/device supplies (calculate dosage as needed). Maintain files of drug/device dispensation, compliance and return
Ensure proper collection, processing, shipment of specimens, and documentation. Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings
Record and document protocol deviations. Communicate with PI and sub-investigators about changes in the trial. Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs. Maintain follow-up to determine resolution of adverse event. Capture and record adverse events data. Compose adverse event reports for oversight agencies
Audit documents and pertinent files and prepare for storage. Archive documents for study per sponsor/government/institutional requirements. Evaluate team effort at site. Document “drop outs” (e.g., causes, contact efforts)

Clinical Research Nurse Oncology Research Resume Examples & Samples

Work requires interpersonal skills necessary to function as liaison between physicians, office staff and the
Ability to listen compassionately, demonstrating effective problem-solving and critical-thinking techniques to
Practical understanding of clinical research is required
Excellent computer/information systems skills including use of EMR required

Clinical Research Nurse Resume Examples & Samples

Coordinating and supporting all study activities, documentation processes and special needs of a clinical study in conjunction with the Senior CR Coordinator, CR Coordinator
Responsibility for medical examinations, subjects safety and medical data documentation according to the case report forms, study protocol and ICH/GCP guidelines
Organisation and Preparation of clinical studies, like
Native German skills (written and spoken)
Good English skills (written and spoken)

Clinical Research Nurse Manager Resume Examples & Samples

Collaborates with principal investigators and sponsors in establishing, implementing and conducting clinical research trials which test the safety, efficacy and toxicity of experimental drugs, vaccines, and devices on KFHP members. Manages the operations of research units at multiple locations
Supervises research staff, assesses their needs, and identifies educational opportunities. Recruits and hires new clinical research staff. Develops training materials and takes responsibility for training of new hires. Directs and designs quality assurance programs for clinical trials. Collaborates in the management of research data. Implements quality assurance programs and develops strategies which improve the quality of research conducted and patient care
Develops and presents quality assurance training programs. Responsibilities for performance evaluations of the research staff. Counsels and disciplines staff members who are non-compliant with applicable policies, procedures, and standards. Manages and resolves human resource, employee, and department issues. Performs as a point person for decision-making and problem solving day to day operation of projects, including the resolution of technical problems and questions of research staff. Acts as patient advocate resolving patient care issues
Designs and evaluates processes to improve systems and patient outcomes across the continuum of care. Participates in design and development of overall clinical plans for the conduction of multiple clinical trials. Develops and implements protocol specific standard operating procedures. Determines and monitors budgets for the appropriate use of human and material resources. Monitors financial performance. Identifies and implements strategies to reduce cost and improve quality. Ensures compliance with KFHP, Nursing Practice Act, federal, state, local and other (The Joint Commission) regulatory requirements which govern the testing of investigational drugs and vaccines
Minimum five (5) years of experience in a research/health care environment to include management and supervisory responsibility; the development of research procedures to support the research design/principles of a particular project; and in-patient and outpatient care experience

Clinical Research Nurse Resume Examples & Samples

Bachelor’s Degree in Nursing or related field and 3 years of experience in the field of clinical research. Knowledge of GCP (Good Clinical Practice) and other FDA regulations pertinent to the conduct of clinical studies
Ability to interface with all levels of employees
Registered Nurse – licensed in the State of Florida
Basic Life Support (BLS) certified

Clinical Research Nurse Resume Examples & Samples

Reviewing medical records; Reviewing clinical and laboratory evaluations; Maintaining appropriate source documentation and appropriately and accurately completing patient charts and/or case reports
Evaluating and enrolling patients in clinical research studies; Obtaining patients’ informed-consent, Collecting scientific samples and detailed, accurate data; Arranging follow up medical care to insure ongoing monitoring of patients in research protocols; Reporting adverse events to principal investigator and/or sponsor in a timely manner
Preparing materials for submission to the IRB and participating in protocol development by drafting study protocols and/or reviewing potential protocols to evaluate their effect on standard nursing procedures; Preparing financial records including quarterly reports, budget, and subject-related expense; Preparing for and completing close out procedures for terminated studies, ensuring all FDA, sponsor, and University regulations have been followed; Acting as a protocol resource for other research team members; Participating actively in clinical meetings, rounds, and departmental meetings
Participating in departmental activities, special projects, and other duties as required or assigned
Current license as a registered nurse with the state of Illinois
Proven knowledge of the principles, practices, and techniques of nursing care
Proven knowledge of health care data management techniques and systems
Proven ability to perform diagnostic testing
Able to articulate and clearly communicate clinical and/or information to patients and other health care professionals
Able to make decisions independently, yet must be team oriented
Proficient in written and spoken English
Efficiency/dependability
Energy/drive
Proficient with Microsoft Office / overall technical aptitude
Previous working experience with IRB, NIH, and A-21 Circular regulations and procedures
Ability to identify and analyze significant problems and opportunities
Willingness to facilitate open and effective communication, cooperation and teamwork within and outside of one’s own team
Ability to work with abstract conceptual matters
Ability to motivate others to buy into ideas or at a situation in a new way
Demonstrated ability to work on multiple projects simultaneously

Clinical Research Nurse Resume Examples & Samples

Oversee care to assure protocol adherence is maintained by staff, serve internally as a resource for nursing (outpatient, inpatient, home care), medical staff and CRO staff; Responsible for collection and documentation of research data for designated patients within program meeting CRO consortia standards; On an as needed basis may be involved in review or documentation of data on patients outside of program area to meet external audit deadlines
Facilitate transfer of nursing responsibilities for patient back to primary nurse (clinic, hospital, BMT) when patient is no longer actively being followed on a clinical trial
Provides input into implementation of protocols including setting, systems issues changes to assure that process will work in other areas if needed within NMH; Present information at weekly meetings in organized fashion; monitors budget for selected aspects of research studies
Participates in development of clinical trials as appropriate; participate in consortia meetings periodically; attends protocol start-up meetings; identifies problem areas in current clinical trials and seeks solutions to optimize quality patient care and assure completion of the trial
Collaborates with the principal investigator in all aspects of research study; Monitors care of patients in accordance with research protocols and Good Clinical Practices and takes action to assure that patient care is delivered in accordance with policies of the particular care setting. (i.e. NMFF, NMH); Ensure that informed consent has been properly obtained; Prepare reports of Serious Adverse events; Communicate with local federal or commercial sponsors as appropriate; Assist CRO Staff with preparation for audits and answers queries promptly
Involved in providing staff education as needed for participation in particular research activities; Provides staff education on general clinical trial information; Assist in orientation of new staff members to CRO; Provides patient education in daily practice; Development of patient education materials or protocol tools specific to research study to facilitate trial compliance (i.e. standardized orders, patient management guidelines for housestaff, patient documentation tolls)
BSN with 3 years clinical practice
Clinical Research Coordinator certification (within 6 months of eligibility)
Involved in external professional organizations (e.g. Oncology Nursing Society, nursing committee co-operative groups) and obtains and maintains OCN certification within 6 months of eligibility if not already certified
CAS; COMP; COW; ENI; HEALTH; QUALITY; RER
Oncology Nurse Certification (OCN®)
Investigational agents, coordination of clinical research and data collection/management
Clinical Research Coordination certification

Clinical Research Nurse Resume Examples & Samples

ARNP highly preferred
Pediatric Nursing in an acute care setting preferred
Experience in neurology, neurosurgery, or oncology preferred
Experienced with database management tools and/or REDCap preferred
Demonstrated knowledge of clinical research trial design and execution
Experienced with electronic medical record and clinical trial management software applications
Effective organizational and project management skills
Ability to comprehend professional and scientific journals
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Proficiency in Microsoft Office including Access, Word, Excel, Outlook, and PowerPoint
Willing to work off-hours depending on the study requirements and willing to travel to offsite locations

Clinical Research Nurse Resume Examples & Samples

An active Registered Nurse (RN) or LPN license in the State of New Jersey
Screens study subjects for eligibility for inclusion into the studies; Provide direct care to research subjects, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects under the guidance of PI, etc
Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol
Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators
Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness
Assists the Clinical Research Coordinator in transcribing study data from source documents to sponsor designated case report forms or records data for remote data entry if applicable
Resolves data queries in conjunction with the sponsor
Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor
Responsible for maintaining emergency medication in the crash cart and regular maintenance of AEDs and defibrillators
Assist pharmacist in test article preparation, dispensing, and dosing
Carries out verbal or written Medical Orders (e.g., dose concomitant medications, closely monitor subject’s vital signs) as requested by the Investigator

Clinical Research Nurse Resume Examples & Samples

Previous research experience, preference given to those with clinical trial experience
Previous experience working with adolescent participants
Previous experience with motivational interviewing
Demonstrated excellence in documentation skills
Exceptional teamwork and interpersonal skills; ability to communicate in a cross-functional environment
Women’s, minority and reproductive health experience will be given priority

Senior Clinical Research Nurse Coordinator Resume Examples & Samples

Review protocols and provide input on study activities in relation to areas of responsibility
Conduct protocol-specific training for study personnel in preparation for study activities
Evaluate adverse events and manage safety reporting activities in a timely manner
Resolve study related questions and/or mitigate issues in conjunction with appropriate clinical research personnel
Ensure proper execution of the informed consent process for all study subjects
Review study subject source records and provide input to Principal Investigator regarding potential subject eligibility, as appropriate
Develop and maintain study forms/tools to facilitate accurate tracking and documentation of relevant study information
Maintain accurate and complete source data in PIMS and/or other source documents and facilitate the resolution of source discrepancies or issues, as appropriate
Facilitate training of new nursing personnel and ensure management is apprised of trainee progress
4 – 8 years of nursing experience
3 - 6 years in clinical research environment
3 – 4 years Clinical Research Nurse Coordinator experience

Senior Clinical Research Nurse Resume Examples & Samples

Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed
Oversees the completion of all End of Study or Early Termination activities by study participants, inclusive of follow up for the close-out of any outstanding items (i.e. AEs, physical exams, lab repeats, etc.) after subjects have been discharged from the clinic
Provides administrative and operational support to ensure successful conduct of study protocols
One to two (1-2) years of experience in a clinical research environment
One to two (1-2) years in a lead role or supervisory experience
Experience onsite at Teva preferred
Able to work independently and handle multiple competing priorities
Able to multi-task working within tight deadlines
Able to function independently within a team environment
Possesses excellent organizational and time-management skills and a strong attention to detail

Rn-clinical Research Nurse Resume Examples & Samples

Ability to apply scientific principles to problem solving, planning, as well as providing and evaluating nursing care
Working knowledge of computer applications including MS Office
Ability to work independently and as part of an inter-disciplinary team
Ability to travel to other off-site clinical sites
Ability to work overtime and nights/weekends/early mornings, as needed

Clinical Research Nurse Resume Examples & Samples

Responsible for coordinating the research activities of assigned IRB-approved study protocols Reports and is responsible to the Principal Investigator (PI) and supports the CID department head in accordance with federal and local regulatory guidelines
Administers investigational drugs as specified in the protocols
Use managerial, communication (written and verbal) and leadership skills in all PI and human subject interaction
Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA)
For consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc
In collaboration with the research pharmacist, ensure correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability
Ensure subjects receive education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable
Ensure adequate inventory of study supplies, including drugs, devices, etc
Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs
Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the execution of a study related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Train appropriate personnel as needed. Maintain documentation of training
Coordinate the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol
Process and prepare specimens for lab analysis and shipping as applicable
Obtain laboratory results and consult with the PI for follow-up care as per protocol
Report adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations
Evaluate compliance of research subject and complete documentation of status and progress
Respond to compliance Officer audit findings and, after consultation with PI, implement approved recommendations
Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol
Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol
Interact on a regular basis with the PI and study team members regarding the conduct of the research study
Return telephone calls from research participants in an efficient and timely manner and document interactions appropriately
Actively participate in CID departmental and command-wide research educational and training programs by providing instruction, presentations, and assistance to research staff as needed
Assist the compliance Officer with monitoring process to ensure protocol compliance
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols
Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency as authorized by the contract
Perform other research related duties as needed
Must be a U.S. citizen. / Must be able to obtain a National Security Clearance
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research
Clinical competence in application of professional nursing theory, practice, and skills for the care of pediatric and adult patients
Skills in counseling, guidance and maintaining interpersonal relationships

Clinical / Research Nurse, OB / GYN Resume Examples & Samples

Recruit study participants, schedule appointments, interview and evaluate potential participants to ensure they meet eligibility requirements; instruct participants concerning protocol and obtain consent signature
Schedule and/or coordinate the scheduling of required laboratory tests and/or exams
Assess participants for evidence of drug toxicity, unexpected side effects or other problems, and notify principal investigator; recommend dosage adjustments per protocol
Train, oversee, and provide current patient information to nurses and other health care personnel in order to assure comprehensive patient care
Document medical data in patient record
Adheres to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as the University of Arizona policies and procedures
Actively participate in clinical research team meetings
Review treatment plans for assigned protocols for accuracy
Bachelor’s degree from a State Board of Nursing approved school of nursing AND two years of professional nursing experience; OR,
Associate’s degree or diploma in Nursing from a State Board of Nursing approved school of nursing AND four years of professional nursing experience
Currently licensed as a Registered Nurse in the State of Arizona
Three (3) years clinical research experience
OB/GYN experience preferred
Master’s degree
Previous work with the EPIC or Cerner electronic health record system

Clinical Research Nurse Coordinator Resume Examples & Samples

Adhere to an IRB approved protocol
Coordinate protocol related research procedures, study visits, and follow-up care
Participate in the informed consent process of study subjects, screen, recruit and enroll patients/research participants
Support the safety of clinical research patients/research participants
Educate subjects and family on protocol, study intervention, study drug, etc
Register study on ClinicalTrial.gov
Facilitate pre-study, site qualification,study initiation, and monitoring visits
Facilitate study close out activities
Coordinate research/project team meetings
Collect, process and ship laboratory specimens
Maintain study source documents and regulatory documents
Report adverse events
Comply with Institutional, federal, state, and sponsor policies, standard operating procedures (SOPs) and guidelines

Clinical Research Nurse Coordinator Resume Examples & Samples

Manage study finances including sponsor invoicing & resolving study subject billing issues
Develop advertisement materials, informed consent document, Case Report Forms
Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Maintain Clinical Trial.gov/
Act as mentor to others for their professional development
Supervise and train new staff
Understand good clinical practice (GCP) and regulatory compliance Comply with Institutional, federal, state, and sponsor policies, standard operating procedures (SOPs) and guidelines
Performs a leadership role in developing, implementing, and evaluating the conduct of clinical research
Administratively support the Neuro-Oncology / NF physicians and study team related to research documentation
Work with clinical team and other research staff to order research procedures including research specimens
Ensuring Investigational Agents and study related requirements are ordered according to the protocol
Coordinate PK/PD studies
Provide nursing care, participate in clinical/protocol rounds, and schedule study related tests in the context of research participation
Review study drug medication compliance for subjects enrolled on clinical trials
Administer patient reported outcome forms as required by study protocols
Assist the study PI in the identification and screening of subjects, and in explaining studies to subjects
Ensure only eligible subjects are enrolled, confirm source documentation for all eligibility and pre-treatment requirements prior to enrollment
Liaison to patients and families for protocol related questions
Serve as liaison to institutional investigators, nurses and pharmacists for information exchange regarding clinical trials as assigned within the Neuro-oncology/NF programs
Initiate and maintain communication with the principal investigator(s) on the status of active projects, regulatory and protocol performance
Participate in the development and implementation of Neuro-Oncology / NF clinical research initiatives
Review inpatient and outpatient progress notes and assessments for protocol compliance and grade toxicities
Assist CRA in chart abstraction, completion of case report forms, data clarification, and ensuring appropriate source documentation is maintained according to sponsor and PI requirements
Communicate study noncompliance with principal investigator(s)
Ensure accurate reporting of toxicity, SAEs, Unanticipated Problems and Protocol Deviations to the IRB, CRQA and Sponsor
Assist CRA in preparation for and facilitate monitor visits and audits; ensure documentation is adequate for study validation and monitoring / audits
Act as research information resource for Neuro-Oncology / NF protocols
Mentor medical staff and contribute to the education of other CRAs/Study Coordinators related to Neuro-Oncology / NF protocols and processes
Demonstrate commitment to patient safety by speaking up about safety issues. Shares errors or potential errors through system reporting mechanisms

Clinical Research Nurse Coordinator Resume Examples & Samples

Facilitates and participates in the following research activities: screening, enrollment, obtaining informed consent, data and specimen collection, data entry and clarification, preparation of relevant data sets and/or databases
Participates in direct patient care only within the scope of assigned clinical research protocols. Educate, coach, and assist in the development of other Research Coordinators, Research Assistants, students and volunteers
Assists in new protocol development. Participates in CQI activities and may facilitate research portion of divisional CQI meetings. Completes Quality Improvement Reviews within the department as assigned
Assists with grant and budget preparation. Helps to support project financial management
Communicates directly with Divisional Research Manager, PIs, and divisional research team. Reports on status of studies under his/her direction. Must be able to frequently interact in a supportive and optimistic manner with physicians, nurses, patients, subjects, families, The CHOP Research Institute, and support staff
Graduate of an NLN-accredited School of Nursing
Minimum 2 -5 years clinical nursing experience
2 years clinical research experience
Pediatric and/or ICU nursing experience

Clinical Research Nurse Resume Examples & Samples

Administer prescribed study medications, perform phlebotomy, draw blood samples, monitor vital signs and/or perform other specialized nursing procedures, as appropriate to the specific needs of the study and individual subjects
Participate in day to day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects
Provide supervision for research tech and clamp tech staff in the performance of nurse related activities including assistance in training on the specifics of phlebotomy and blood draws, proper care of specimens, and properly obtaining urine samples
Assess and monitor all AEs of subjects
Assist in keeping adequate stock of consumable clinical inventory
RN degree from an accredited institution
Active license to practice in the state of Nevada
1 year experience as RN
Ability to function with multiple types of individuals and work in a team environment while maintaining a positive attitude
Strong planning and organizational capabilities to manage multiple tasks and study groups at one time
Willingness and ability to learn administer investigational drugs including oral, intravenous, topical, or other approved method of dosing
Willingness and ability to learn and perform a variety of technical procedures such as drawing blood, processing and harvesting lab specimens, taking vital signs, performing ECGs, etc
Ability to work a flexible schedule to meet the study needs of the Dental Clinic
Good handwriting and attention to detail

Clinical Research Nurse Resume Examples & Samples

Screens all potential and physician-referred patients for protocol eligibility. Maintains and submits monthly screening logs
Presents trial concepts and details to the patients, and participates in the informed consent process under the direction of the physician
Documents informed consent process and all components of protocol treatment. Participates in ongoing patient education. Coordinates scheduling of tests and treatments required for the protocol. Maintains research patient database according to US Oncology Research (USOR) Standard Operating Procedure (SOP)
Assesses patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly documents all findings
Works directly with the physician/investigator and clinic staff to ensure protocol compliance
Reports to practice operations and physicians regarding monthly accrual statistics and financial status. May be responsible for creating budgets for the research department. Coordinates payment of non-standard of care protocol-required procedures in order to be compliant with federal and state billing regulations
Ensures accurate and complete data collection, entry, and timely submission to central operations in accordance with USOR SOP
Coordinates research drug procurement and accountability records in accordance with USOR SOP
Participates in and supports all site auditing and monitoring visits
Maintains protocol regulatory documents in compliance with USOR SOP. Communicates, reviews, and documents weekly Regulatory Memoranda with physicians and other clinic staff as appropriate
Oversees local quality assurance program and develops appropriate action plans for quality improvement
Actively participates in protocol initiations and study specific educational programs. Communicates and collaborates on an ongoing basis with central operations
Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law
Graduate from an accredited RN program and bachelors in science or healthcare field is required (BSN preferred)
Three years of clinical research experience required (candidates with oncology experience require 18 months experience)
Current licensure as a registered nurse in state of Nevada
Current BLCS or ACLS certification required
SoCRA or ACRP certification preferred
Knowledge of medical terminology, nursing assessment, clinical trials and GCP concepts
Experience with computer data entry and database management
Ability to read, analyze and interpret technical procedures such as protocols, informed consent documents and regulatory documents

Clinical Research Nurse Resume Examples & Samples

Excellent written and interpersonal communication skills
Proficient in use of Windows based MSOffice (Word and Excel). Familiar with the use of standard office equipment
Comprehensive understanding of medical terminology
Experience in use of clinical trial protocols preferred
Demonstrates ability to coordinate and prioritize diverse tasks
Ability to interpret data, adapt and apply guidelines of research principals
Five years clinical or related experience
Must possess the knowledge of clinical, psychosocial and path/physiological theories related to nursing diagnosis and treatment and can competently perform the range of nursing techniques found in general nursing practice as normally acquired through completion of an accredited nursing program
Maintains CPR certification

Clinical Research Nurse Coordinator Abdominal Transplant Resume Examples & Samples

Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collectiondocuments and instruments. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and dataprovenance. Map protocol data flow. Predict areas of vulnerability for a protocols data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution
Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team
Nursing activities. Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures. Delegatetasks and supervise the activities of other licensed and unlicensed research staff. Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Complete 18 hours of Continuing Education per year. Maintain compliance with required hospital and unit specific training competencies

Clinical Research Nurse Resume Examples & Samples

Serves as liaison between clinical and laboratory personnel and the NCI Developmental Therapeutics Principal Investigators
Participates in clinical trials protocol development
Develops procedure manuals for clinical trials protocols
Assists in the creation of case report forms
Advises on and participates in the management and evaluation of multiple clinical protocols
Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
Interfaces with the Protocol Support Office
Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
Interacts with auditing and monitoring agencies to facilitate the exchange of data
Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
Monitors and oversees activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials
Ensures quality and human subjects protection
Assists with writing protocols and protocol amendments to ensure regulatory requirements
Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
May conduct updates for clinical staff on patient care, protocol process and progress, human subjects protection, ICH Good Clinical Practices, and quality assurance education
May visit off-site collaborative centers
Work is performed independently under the general guidance and direction of the supervisor
Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed. Current State license as a registered nurse (RN)
6 + months nursing and/or related clinical research experience
Demonstrated experience in the coordination, implementation, and execution of clinical trials
Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
Oncology experience
Experience in a clinical trials outpatient setting and/or experience in data management and collection

Clinical Research Nurse Manager Resume Examples & Samples

Manages and monitors policies, practices and procedures of licensed and unlicensed staff in their assigned translational working group (includes C&T and M&P staff)
Ensure infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulation while ensuring participant safety. Includes assigning nursing and research support staff to the disease team specific clinical trials
Hires, trains, supervises and evaluates staff providing direction, training, support on a variety of research topics, including but not limited to: Informed Consent, enrolling study subjects, data management and monitoring/auditing of studies
Collaborate with Therapeutic Working Group Leader (TWG) and Principal Investigator (PI) on assessment and implementation of highly complex trials for the research team. Includes identifying accrual targets, study activation timelines and metrics and resolving potential discrepancies and/or barriers to enrollment by prior to study activation
Implements and manages internal practices of assigned translational working group that ensure compliance with University and federal requirements
Manage oversight of protocol conduct and ensure that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements
Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring visits, Multi-disciplinary Team meetings, staff meetings
Liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner for projects within their assigned translational working group
Liaison between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned translational working group

Clinical Research Nurse Resume Examples & Samples

Strong computer skills to include advanced use of Word and Excel software programs, internet and email
Demonstrated ability to consistently display accuracy and attention to detail
Demonstrated ability to communicate effectively one-to-one, in small groups and in public speaking contexts
Ability to write precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar
Experience planning and preparing procedures, performing tests, interpreting records and communicating results
Effectively performs duties and responsibilities with attention to detail and support for organizational policies
Exhibited energy and a strong desire to achieve
Demonstrated energy and desire to achieve and ability to take action that no one has requested to improve or enhance job results and avoid problems
Demonstrated logic, rationality and objectivity and ability to use all available information to make educated decisions
Proficient with Microsoft Office (Word, Excel, PowerPoint, and Access)
Ability to plan, organize and schedule in an efficient, productive manner and target projects or initiatives that require special attention and focus on key tasks when faced with limited time and/or resources
Previous experience with diabetes care or research; and
Previous experience with IRB and NIH regulations and procedures
Willingness to facilitate open and effective communication, cooperation and teamwork within and outside of one's own team
Demonstrated ability to work on multiple projects simultaneously; OR appropriate combination of education and experience

Clinical Research Nurse Oncology Resume Examples & Samples

Serves as primary study coordinator for research protocols performed at the Inova Schar Cancer Institute
Directs the conduct of clinical studies to ensure adherence to the research protocol, institutional policies, and applicable federal and state regulations
Screens patient records for identification of prospective candidates for research protocols
Educates potential research participants about research protocols and obtains informed consent in accordance with institutional policy, IRB guidance, and applicable regulatory requirements
Participates in site initiation visits and investigator meetings for assigned clinical trials (may involve occasional travel)
Provide education for hospital /clinic personnel about upcoming and ongoing research protocols
Record research activities in clinical trial management system (CTMS)
Coordinates the collection of data according to the research protocol and other study documents
Draws, prepares, and ships laboratory samples for clinical trials
Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines
Partner with study investigators to ensure compliance with the study protocol and advises investigators on the results of procedures and tests; calling to attention findings of clinical importance
Documents patient interactions and visits in electronic medical records
Schedules follow-up visits for study patients according to the study protocol and clinic schedule
Schedules and supports sponsor initiated monitor visits and quality assurance audits for periodic reviewing and querying of collected data in a timely fashion
Identifies strategies to improve patient enrollment in research protocols in collaboration with Principal Investigator
Assists investigators in drafting research protocols and publications. Performs literature searches and statistical analysis in support of these activities

Clinical Research Nurse, RN Resume Examples & Samples

Assisting with all IRB submissions and all IRB documentation
Assisting with all regulatory document preparation and submissions, including documentation for the FDA
Recruiting and enrolling patients in research studies. This will include obtaining appropriate consent/assent, educating patients/parents, scheduling and conducting study procedures, collecting and recording study data, maintaining study records and participating in care coordination, when necessary
Obtaining any training necessary to perform research procedures with the understanding that training may be off site
Actively participating in the writing of research protocols and all research meetings and journal clubs (which will require individual to maintain a working knowledge of the literature pertaining to relevant research projects)
If individual is an APN or patients are actively enrolled in research studies, research APN may perform study visit physical exams
Traveling to national meetings as deemed beneficial to the research
Functioning as a resource for the medical staff, patient/family and community, providing educational information and expertise in the area of sickle cell disease research
Responsible for participation in departmental and hospital programs for continuous improvement
Other duties necessary to successful completion of research studies
The individual recruited for this position will be actively involved in all aspects of the Sickle Cell Disease Program. Although the conduct of sickle cell-related clinical trials will be the primary responsibility, at the discretion of the Program Director, this individual will be a full participant in the clinical program and will be involved in many aspects of patient care
Follows all aspects of Standard Operating Procedures and Good Clinical Practice in the conduct of clinical care delivery and research; collects and prepares documents as required; attends Investigator Meetings as assigned
Develops source documents for submission to IRB; coordinates IRB submissions for assigned studies; maintains regulatory documents during conduct of study; develops and utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies
Participates in the conduct of parental permission/assent process for assigned studies; develops strategies to ensure compliance of study participants with protocol requirements
Coordinates monitoring activities; completes case report forms; responds to sponsor queries, prepares for audits, IRB and/or the FDA/DHHS
Performs clinical data gathering and measurements; maintains study databases; compiles and analyses data retrieved from ongoing clinical trials
Assists in identifying, reporting and following up on Serious Adverse Events
Participates in training nursing and ancillary staff for study purposes; participates in study recruitment, screening and enrollment so that protocol enrollment requirements are met
Assists with care coordination with family and other community partners to ensure comprehensive clinical care delivery
Acts as resource person and point of contact to staff and community with regards to clinical trials and current treatment modalities
The individual recruited for this position will be actively involved in all aspects of the Sickle Cell Disease Program. Although the conduct of sickle cell-related clinical trials will be their primary responsibility, this individual will be expected to perform other clinical or administrative duties at the discretion of his/her supervisors. These will include inpatient and outpatient clinical duties at APN level as needed to support clinical and research needs of the program
Conforms to Standard Operating Procedures (SOPs) and Good Clinical Practice guidance; provides constructive critical assessments of proposed studies; seeks and accepts reasonable clarification of established policy from Lead Investigator
Maintains the highest possible standards for work quality; takes direction, accepts supervisory feedback and works with supervisors to accomplish change as necessary
Builds and fosters professional relationships with staff, families and patients
Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently when required
Sets priorities; thinks proactively; demonstrates adaptability/resourcefulness
Realizes and accepts limitations

Clinical Research Nurse Resume Examples & Samples

Personal qualities and interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
Detail oriented and teamwork skills
Motivated, organized, able to perform multiple tasks in a timely manner, and work efficiently under pressure
Ability to manage multiple clinical trials and function independently
Critical thinker and possess an analytical approach to problem solving
Able to perform diverse clinical and clerical duties
Working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet knowledge skills
Knowledge of the levels of growth and development and aging for the adult and geriatric patient population for the adult research coordinators or demonstrates knowledge of the levels of growth, development and skills of children between the ages of birth though 18 years of age for pediatric research coordinators
Laboratory specimen preparation and handling (Preferred)
Bilingual (Preferred)
Graduate of a school of nursing, physician assistant-certified, or advanced registered nurse practitioner
Minimum 2 years’ experience as a Registered Nurse or 2 years’ experience in clinical setting if PA
Proven track record of conducting clinical research studies in a hospital surgical setting highly preferred (Preferred)
BSN or MSN (Preferred)
Prior research experience, work with research groups (Preferred)
Research experience in coordinating phase II-IV clinical trials
Experience with critical care, dialysis, hepatology, cardiology, or transplant (Preferred)
Current registration with Florida State Board of Nursing, as applicable to clinical designation—RN, ARNP, or PA
Certificate from clinical research professional organization, i.e. SOCRA, ACRP (Preferred)
Demonstrates through behavior Florida Hospital’s core values of Integrity, Compassion, Balance, Excellence, Stewardship, and Teamwork as outlined in the organization’s Performance Excellence Program booklet
Responsible for maintaining professional knowledge and growth, as well as, contributes to the growth of team members
Identification of potential clinical trial candidates, confirmation of eligibility and enrollment of patients is a responsibility of the Research Nurse. These are not responsibilities of the Clinical Research Coordinators
Responsible for reviewing all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, NCI, and state, federal and institutional regulations with study candidates and/or legal representative
Ensures, through patient advocacy and informed consent as an ongoing process, that the rights, safety, and well-being of trial subjects are the most important considerations and should prevail over the interests of science and society
Responsible for the immediate oversight of the study conduct during the pre-study, active and follow up phase, both inpatient and outpatient
Responsible for accurate and timely submission of data forms, radiology, radiotherapy, and pathology materials during the active and follow up phase of the study
Responsible for communicating with the investigational pharmacist and medical staff when investigational drugs are being administered
Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator, Supervisor and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects
Participates and supports in Multidisciplinary Spine Conferences, Tumor Boards, Journal Clubs, and other physician education venues. Supports FH Altamonte regarding these physician programs and assists as requested with program activities. Communicates recommendations to all involved physicians (including primary care physicians) and other health care providers
Works flexible hours and is available as a resource for questions related to research projects. This may include overnight travel and call time
Reads and interprets medical records; operates various pieces of equipment. Utilizes current clinical skills, draws blood, and performs CPR and any other required duties

Clinical Research Nurse Resume Examples & Samples

Interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
Detail oriented and teamwork skills; must be motivated, organized, able to perform multiple tasks in a timely manner, and work efficiently under pressure
Manage multiple clinical trials (usually simultaneously) and function independently; perform diverse clinical and clerical duties
Critical thinker and an analytical approach to problem-solving
Working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet knowledge and skills
Knowledge of the levels of growth and development and aging for the adult and geriatric patient population for the adult Clinical Research Nurse OR
Knowledge of the levels of growth, development, and skills of children between the ages of birth through 18 years of age for the pediatric Clinical Research Nurse
If in Diabetes Research (1230) – Specialized knowledge of the unique needs of diabetes patients undergoing treatment in clinical trials
Associate’s degree in Nursing
Minimum 2 years nursing experience, with most recent 1 year in clinical research
Bachelor of Science in Nursing or healthcare-related field
Master’s degree in Nursing or healthcare-related field
Current, valid State of Florida license as registered professional nurse
Maintain professional knowledge and growth, as well as contribute to the growth of team members
Identification and confirmation of eligibility and enrollment of research subjects
Review all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, state, federal and institutional regulations with study candidates and/or legal representative; demonstrates through patient advocacy and informed consent as an ongoing process, that the rights, safety and well being of trial subjects are the most important considerations and should prevail over the interests of science and society
Immediate oversight of the study conduct during the pre-study, active and follow up phase; performs accurate and legible documentation; manages records, study medication, and test articles in a confidential, timely, and secure manner
Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Supervisor and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations
Provides input into research protocol selection and coordinates study related communications with Research Team, patients, FH departments and customers (Sponsors, Clinical Research Organizations {CRO} and Study Monitors) in clinical research

Clinical Research Nurse Resume Examples & Samples

Be responsible for screening, assessing eligibility, and enrolling patients in clinical trials
Prepare and submit IRB documents,as required
Work on surgical outcome studies, general surgical device and drug studies
CPR/BLS cad required
Prior research experience/clinical trials preferred
Prior experience with surgical patients preferred

Clinical Research Nurse Resume Examples & Samples

Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's degree in nursing; OR appropriate combination of education and experience
Experience with Coordinating the work of others; Collaboration; Organization Communication; Case management; Diagnostic Testing; Emergency Response
Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook)
Strong organization skills/attention to detail
Previous experience with IRB, NIH, A-21 Circular regulations and procedures

Clinical Research Nurse Translational Research Institute Orlando Resume Examples & Samples

Ability to perform clinical tasks such as phlebotomy, peripheral IV line insertion, and assisting physicians and providers with procedures
Ability to handle multiple tasks, simultaneously, in an organized and timely manner
Ability to work independently and as a team under the direction of the Investigator, PM, and Clinical Operations Manager
Critical-thinking skills
Computer skills, particularly Microsoft Outlook, Word, Excel, Publisher, Powerpoint; use of internet and other research tools (preferred)
Knowledge of clinical/translational research and research regulatory environment (preferred)
Experience in the clinical/translational research environment (preferred)
Current active RN licensure with the Florida State Board of Nursing
ACLS certified (preferred)

Clinical Research Nurse Resume Examples & Samples

Facilitates, maintains, and coordinates the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures, applicable nursing practices and sponsor requirements
Provides direct nursing patient care including, but not limited to inpatient admission and discharge, where applicable, diagnosis, administration of medications, and performance of applicable clinical study-related tests as well as maintaining continual clinical assessment of study subjects under the direction of the principal investigator or supervising physician
Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required
Arranges for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study
Schedules and leads in-house protocol meetings to review study-related procedures, staffing and visit flow
Schedules and coordinates all medical needs and coverage for protocol related procedures
Maintains and documents all study-related communication including, but not limited to the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s) and IRB throughout the clinical trial
Responsible for giving subject instructions for study participation and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events
Ensures all protocol procedures are completed per study requirements
Obtains and documents all adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations and applicable policies and procedures
Assures quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval
Ensures accurate, complete and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval
Schedules, leads and assists with all study-related visits on site and is readily available during visits for applicable corrections, questions, or other study-related or site needs
Supervises document retention, security and destruction, where applicable
Responsible for completing all necessary training for the position, including study protocol specific training and Health System policies and procedures
Trains other study specific research staff in collection and reporting of required data, where applicable
Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents, where applicable
Travels between hospital locations where research is conducted
Performs all other functions as related to this job and assigned
Bachelors degree or equivalent experience
Two years’ experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice
Intermediate computer and internet knowledge
Excellent customer service and patient care skills
Meticulous organizational skills
Excellent demonstrated written and verbal communication abilities
Three to Five years’ experience in clinical research trials
ACRP or SOCRA certification

Clinical Research Nurse Resume Examples & Samples

Valid California RN license and graduation from an accredited school of nursing. With six months of clinical experience, and experience working with HIV/HCV infected patients
Expert knowledge and experience with standard patient care equipment such as EKG, oximeter, blood pressure monitor, IV pumps, phlebotomy, saline locks, assisting with biopsies, LP's, etc
Knowledge of a broad range of medications, indications, dosage ranges, side effects, and potential toxicity including some exposure to current HIV/HCV medications
Ability to draw blood, start IV lines, collect specimens and administer medications via all routes
Valid CPR, BART, or BLS certification
Knowledge and skill to be able to elicit confidential, private information from patients for research purposes including sexual practices, sexual and needle sharing partners, drug use, etc
Experience in recognizing adverse events in patients with complex disease processes such as HIV and HCV, ability to communicate events to Admin Nurse and PI in a timely manner, ability to describe AE in detail both orally and written word
Computer literacy including knowledge of Outlook, Word, Excel, Power Point, various Internet browsers

Clinical Research Nurse Resume Examples & Samples

1) Participating in the review and preparation of protocols for original and government clinical trials
2) Regulatory involvement: preparing and processing all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting; collect and report timely, valid accurate data, maintain individual patient records
3) Traveling to and attending meetings for the MFMU network at NIH. Duties including preparing statistics for each study and presenting them at these meetings
4) Be responsible for registering and maintaining clinicaltrials.gov site for all interventional trials
5) Recruitment and retention: Interview and evaluate participants as potential candidates for various studies enrollment. Coordinate scheduling of trial participants visits with study investigators and clinical research coordinators as per protocol. Provide clinical services, including phlebotomy and pelvic exams at time of participant visits and when necessary. Provide oversight of administration of medications, study drugs, or study interventions, as appropriate
6) Nursing duties: It is expected that the nurse will be able to perform routine obstetrical procedures such as phlebotomy, pelvic exams, and basic sonogram. (Teaching of these duties can be done if there is not proficiency)
7) Data abstraction and quality: Overall data quality will be the responsibility of the research nurse. Responsible for data collection and management in accordance with trial protocol. Responsible for maintenance of source documents and case report forms
8) Collaboration with MCHRP research team. Plan, direct, and assess overall study management of patient in collaboration with providers and clinical research coordinators. Intercept and respond to trial participants phone calls. Perform telephone follow-up per study protocol
9) Maintain study compliance and integrity through close collaboration with investigators and clinical research coordinators as well as the patient. Participate in the conduct of audits by study sponsors, the FDA, and other groups. Adhere to all University of Pennsylvania, Informed Consent Form (ICF), and FDA guidelines. Provide ongoing service education updates to all investigators and HUP staff that have eligible participants for clinical research studies

Clinical Research Nurse Coordinator Resume Examples & Samples

Coordinates the evaluation, treatment, ambulatory care, inpatient and home care for patients on clinical research trials in the Massey Cancer Center in collaboration with all members of the health care team, including case-finding and evaluation of potential clinical trial patients
Coordinates and designs systems to collect data, supervises data managers and interfaces with agencies and groups related to the research process
Collaborates closely with Principal Investigator (PI) and clinical research team to ensure that key federal/state/local regulatory requirements are followed; that institutional operational research objectives are met; and that ethical obligations are kept
Develops, establishes and maintains productive relationships with VCU colleagues, all customers and contacts at affiliate sites to achieve essential research outcomes. Meets directly with patients at their locations

Clinical Research Nurse Resume Examples & Samples

Develops and tracks work flow policies, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history
Manages patient care in compliance with the research study or clinical trial protocol requirements. Monitors subject condition while ensuring safety and maintaining confidentiality. Identifies patient problems and makes adjustments to care plans
Serves as a patient advocate throughout the research study or clinical trial. Develops and conducts patient and family education
Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educates and trains personnel on compliance and protocol. Identifies protocol problems, informs investigators, and assists in problem resolution efforts
Manages complex research study or clinical trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data
Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports. Provides expertise in identifying and writing research grants, publications in medical and nursing literature, study materials, brochures, and correspondence
Reviews proposed research study and clinical trial protocols to evaluate factors such as sample collection process, facility location, data management plans, and potential subject risks. Conducts quality assurance audits on data and regulatory documentation. May identify potential research study and clinical trial opportunities
Significantly contributes to budget development, expenditure adherence, grant applications, contract negotiation, and maintenance of inventory on equipment and supplies
Administer and implement treatment procedures or drugs, monitors and studies their effects, and conducts subject medical evaluations
Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts
Provides ongoing training and guidance to less experienced research and nursing personnel
Possesses a knowledge of position requirements and able to perform position in compliance with all requirements/regulations/laws. Ability to understand and utilized scientific/medical terminology and research theory. Ability to gain knowledge and meet the reporting needs of UMB policies and practices for Institutional Review, Human Protections, Animal Protections, etc. Comprehensive knowledge of research principles and practices. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assumes personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Maintains productivity and uses knowledge strategies to increase knowledge base. Skill in continuously seeking to improve the quality of services and processes
Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Writes and presents information in a clear and concise way. Interprets and understands written information and is able to listen attentively to verbal and non-verbal cues that lead to a deeper understanding. Skill in ethically communicating risks and benefits. Ability to maintain confidentiality
Ability to work cooperatively with others and demonstrates professional, ethical, respectful, and courteous behavior when interacting with others. Capable of interacting pleasantly and positively with other to meet customer expectations, and provide follow up with customers
Skill in patient care and ability to administer medication and treatments. Ability to handle emergency medical situations. Ability to handle medical instruments and equipment

Clinical Research Nurse Resume Examples & Samples

Oversees all aspects of a clinical trial from protocol development through closure, including key elements listed, such as interactions with study participants, ensuring informed consent and compliance with protocol; monitor subject symptoms; manage continuity of care, and overseeing quality control and data entry
Determines recruitment strategy, project timeline and work plan to accomplish project (or program), deliverables
Consults with Principal Investigator (PI), clinical research manager, and study monitor to clarify techniques and negotiate deliverables. Apprises them of project status
Administer and implement treatment procedures or drugs, monitors and studies their effects, and conducts subject medical evaluations. Responsible for performing phlebotomy tasks
May coordinate grant applications, literature reviews or perform other research support activities
Possess knowledge of key practices in the field of clinical research as well as all relevant federal, state, local laws regulations and policies. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assume personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Skill in meeting multiple priorities for studies in various stages of development. Maintain productivity and uses knowledge strategies to increase knowledge base. Ability to manage resources as diverse as budget, availability of examination rooms, and use of staff
Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Skill in ethically communicating project risks and benefits. Writes and presents information in a clear and concise way. Interprets and understands written information and is able to listen attentively to verbal and non-verbal cues that lead to a deeper understanding

Clinical Research Nurse Manager Resume Examples & Samples

Bachelor of Science in Nursing, plus five (5) years of related experience
Current California RN license. Must obtain CA RN license within 90 days of start date
Prefer Certification/Licensure in: Oncology Nurse Certification (OCN, AOCN, AOCNS, or AOCNP) and certification by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
Five to ten years clinical research and supervisory experience, oncology preferred

Hematology Clinical Research Nurse Resume Examples & Samples

Current American Heart Association BLS Certification required
Two or more years experience in Medical Oncology
OCN preferred

Clinical Research Nurse Resume Examples & Samples

Recruits, interviews and obtains informed consent from prospective subjects for entrance into clinical trials and studies
Coordinators appropriate laboratory tests and other procedures for subjects participating in studies; including drawing blood or collection of other samples
Coordinates with Investigational Pharmacy for subjects to receive required drugs
Communicates with Sponsored Programs Administration to ensure proper management of charges and billing
Coordinates and submits IRB protocols, reports, revisions, updates, approvals
Records appropriate clinical and laboratory data on forms provided by the principal investigator(s), federal government, and/or industry sponsors
Communicates with study sponsors, federal agencies, principal investigators, and sub-investigators about research projects
Provides resources for staff, patients, families. and community regarding research
Travels to clinical research sites, hospitals, physician offices, and facilities within Carolinas HealthCare System as necessary
Performs other duties as assigned within department

Clinical Research Nurse Resume Examples & Samples

An active Registered Nurse (RN) or LPN license in the State of New Jersey American Heart Association – Basic Life Support
Certificate Experience: A desired candidate will have minimum of 1 year experience in clinical research
Recent nurse graduate is acceptable and will provide on-job training
A knowledge of FDA regulatory requirements and GCP for clinical research
Team work, good communication skills, and detail oriented. Computer skills
Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures
Develops a strategy for implementing study procedures in compliance with the study protocol
Records study data in the source documents
Evaluates and reviews study data to ensure accuracy and completeness

Clinical Research Nurse Resume Examples & Samples

Bachelor’s Degree or appropriate combination of education and experience
Accredited Nursing Program
1 or more years of relevant experience
Microsoft Office Excel, Microsoft Office Outlook, Microsoft Office Powerpoint, Microsoft Office Word

Clinical Research Nurse Coordinator Abdominal Transplant Resume Examples & Samples

Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and therisks and benefits of study participation
Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place
Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution
Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team. 8. Nursing activities. Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures. Delegate tasks and supervise the activities of other licensed and unlicensed research staff. Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities

RN Clinical Research Nurse Resume Examples & Samples

Minimum of one year of RN experience in Oncology or Research - OR-
Previous direct patient care experience and minimum of one year research experience
Certification as an OCN or research certification encouraged

Clinical Research Nurse Coordinator, Senior Resume Examples & Samples

Scientific concepts and research design. Train others in the basic concepts of study design. Conduct and synthesize literature reviews, and independently develop proposals or protocols
Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups
Nursing activities. Plan, provide, supervise and document professional research nursing activities utilizing the nursing process for research subjects in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients

Clinical Research Nurse Supervisor Resume Examples & Samples

Possession of the legal requirements to practice as a Registered Nurse as determined by the California Board of Registered Nursing and six months of clinical experience; theoretical knowledge in a social science or basic science related field
Valid CPR or BART certification or BLS
Demonstrated experience in human subjects research, protocol procedures, and recruitment
Demonstrated experience supervising staff including recruiting, hiring, training and supervision of research staff
Demonstrated ability to work with a diverse group of researchers, administrators, health care professionals and industry sponsors
Demonstrated experience conducting interviews related to HIV risk factors with research participants with the ability to maintain strict confidentiality
Clinical Research experience in phase I-IV studies
Demonstrated experience with policy and procedure generation and implementation
Demonstrated experience with protocol design and implementation

Clinical Research Nurse Resume Examples & Samples

Bachelor of Science degree in Nursing with at least six months of clinical experience
Current California RN license: Possession of the legal requirements to practice as a Registered Nurse as determined by the California Board of Registered Nursing
Current American Heart Association BLS
Demonstrated competence in the following areas: phlebotomy, medication administration, IV insertion, EKG, medication administration (i.e. IV therapy, IM, SQ injections), excellent communication skills, leadership/problem identification/resolution, precise documentation, and teaching of patients, families, staff and colleagues
Competence in the use of PC compatible software including MS Office, proficient in Word, Excel, Outlook
Ability to develop therapeutic relationships with patients with behavioral and cognitive disorders and their families
Demonstrated experience working independently as a nurse and exercising independent clinical judgment
Ability to escalate significant adverse changes or clinical findings through appropriate chain of command
Ability to prioritize and perform multiple tasks with competing deadlines in a fast paced environment
Attention to detail and strong organizational skills
Recent experience in clinical research (i.e. FDA clinical trials experience)
In-depth knowledge of neurological conditions and an understanding of neurodegenerative conditions (i.e. Alzheimer’s disease and other dementias, multiple sclerosis)
Documented training on Good Clinical Practice (GCP)
Knowledge of University guidelines, IRB/CHR requirements

Clinical Research Nurse Adn-days Resume Examples & Samples

Current California RN License,
Associate Degree in Nursing required; BSN preferred
Previous experience as a clinical research RN preferred
ONS Chemotherapy/Biotherapy certification, Human subjects protection training (can be completed after hire)

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