Clinical Research Specialist Resume Samples

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BT
B Torp
Braeden
Torp
9248 Shirley Union
Boston
MA
+1 (555) 835 5955
9248 Shirley Union
Boston
MA
Phone
p +1 (555) 835 5955
Experience Experience
Los Angeles, CA
Clinical Research Specialist
Los Angeles, CA
Thiel, Kuhlman and Stamm
Los Angeles, CA
Clinical Research Specialist
  • Performing data collection through patient chart review, maintaining databases, obtaining participation consent and other forms from patients
  • Maintain and manage study equipment, including troubleshooting/monitoring of subjects’ study computers
  • Oversee proper handling of laboratory specimens including processes, shipping, storage, and documentation
  • Assist with budget development, invoicing for adverse events, billing compliance and patient billing resolution
  • Identify and schedule screening procedures and review results. Assist in the preparation for monitoring visits
  • Provides guidance regarding project planning, project logistics, and project implementation
  • Assist in the development and writing of clinical trial monitoring plans
Houston, TX
Associate Clinical Research Specialist
Houston, TX
Borer Group
Houston, TX
Associate Clinical Research Specialist
  • Assists clinical management with other duties as requested
  • Assist in the preparation and review of data
  • Contributes to ongoing department improvement/standardization initiatives
  • Assist in site initiation activities (e.g. study start-up documentation preparation)
  • Assists with study closure activities
  • May assist sites with answers to protocol questions, regulations, and screening of patients
  • May assist sites with information to answer IRB questions
present
New York, NY
Principal Clinical Research Specialist
New York, NY
Nikolaus, Spencer and Quigley
present
New York, NY
Principal Clinical Research Specialist
present
  • Provides project and study management and assures successful conduct of assigned clinical studies/projects
  • Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes
  • Establishes selection criteria for principal investigators and investigative sites and drives center selection process
  • Responsible for site identification, qualification, initiation, training to ensure study compliance and subject protection
  • Assures training of investigators, center staff and Medtronic clinical staff
  • Facilitates meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees
  • Enlists support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team
Education Education
Bachelor’s Degree in Allied Health Professions With
Bachelor’s Degree in Allied Health Professions With
Boston University
Bachelor’s Degree in Allied Health Professions With
Skills Skills
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Ability to understand and interpret statistical results of clinical studies and understand good data management practices
  • Ability to execute tasks quickly and with meticulous accuracy and consistency
  • Knowledgeable of relevant regulatory guidelines
  • Ability to work with health care professionals at all levels
  • Ability to manage multiple tasks, good prioritization and organizational skills
  • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
  • Excellent Communication Skills and the ability to work with a multi-disciplinary research team
  • Demonstrated knowledge and experience in clinical research, quality regulatory compliance and adverse event reporting
  • Results and quality oriented
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15 Clinical Research Specialist resume templates

1

Clinical Research Specialist Resume Examples & Samples

  • Preferred education in engineering, life sciences or related medical/scientific field, RN preferred
  • Experience with Medical Device Industry
  • Clinical Research Work Experience directly supporting clinical research or similar experience in a medical/scientific area
  • Nursing/clinical work history preferred
  • Clinical Operations exposure
  • Experience interfacing with CRO teams
  • International clinical trial management experience
  • Ability to speak multiple languages
  • CDE (certified diabetes educator) or CCRA certification (Certified Clinical Research Association) or equivalent preferred
  • Self-starter who is willing to work very independently and is self-directed
  • Advanced written and oral communications skills with proficient knowledge of medical terminology
  • Excellent interpersonal communication skills
  • Demonstrated ability to work effectively on cross-functional teams (including R&D, Marketing, Operations)
  • Advanced computer literacy with MS Word, Excel and PowerPoint
2

Country Clinical Research Specialist Resume Examples & Samples

  • Manages local study activities, for instance
  • Bachelor's Degree in related field and 4 years of clinical trial management experience,
  • 2-4 years' experience directly supporting clinical research or similar experience in a medical/scientific area
  • Knowledge: Applies advanced in-depth knowledge in one job family or broad knowledge across a job function
  • Problem Solving: Provides solutions to a wide range of problems
  • Discretion / Latitude: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives
  • Impact: Exerts some influence on the overall objectives and long range goals of the organization and contributes to the completion of work group objectives. Failure to obtain results or erroneous decisions or recommendations would typically result in moderate impact on customers and/or results and considerable expenditure of resources
  • Liaison: Internal interactions extend beyond the immediate work group and include interaction with management. External interactions are primarily to solve problems or improve processes. Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. Leads briefings with internal and external contacts
  • Demonstrated drive and follow through for large and complex clinical programmes and deliverables
  • Risk mitigation skills
  • Demonstrated and consistent project planning experience
  • Project execution and deliverable follow through
  • Resolves routine issues independently
  • Ability to work well under pressure and maintain positive, enthusiastic attitude
  • Eagerness to learn and expand responsibilities
  • Ability to work effectively in a team environment and build strong working relationships
  • Travel maybe required(approx. 5%)
3

Senior Clinical Research Specialist Resume Examples & Samples

  • Bachelors Degree in a scientific field of study
  • Minimum 3 years experience directly supporting clinical research or relevant experience in medical/scientific area
  • Masters degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience
  • Results and solution oriented
  • Excellent problem solving skills
  • Flexible and dependable
4

Clinical Research Specialist Resume Examples & Samples

  • Bachelor’s Degree in a scientific field of study
  • Minimum 3 years’ experience directly supporting clinical research or relevant experience in medical/scientific area
  • Master’s degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Good prioritization and organizational skills
  • Works effectively on cross-functional teams
  • Oversight of a clinical study including enrollment, long-term follow-up, trial master file maintenance and study activation phases
  • Ensure site compliance in regulatory requirements in regards to tracking site activation documents and ongoing study files by performing study file audits
  • Track device accountability reconciliation
  • Evaluate protocol deviation data during the conduct of the study and for completion of clinical study deviation trending requirements
  • Prepare weekly study reports and record meeting minutes
  • Assist in planning, coordination and preparation of meeting materials for investigator meetings
  • Regularly communicates study status to management
5

Clinical Research Specialist Resume Examples & Samples

  • Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI Monitoring standards and guidelines
  • Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
  • Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification)
  • BS/BA degree required; Master’s preferred
  • 3+ years of progressively responsible clinical trials experience, with 1+ years of monitoring experience preferred
  • Expertise in research ethics and the responsible conduct of research
  • Requires excellent verbal and written communication skills with an in-depth knowledge of GCP guidelines, medical terminology, and the clinical trial process
  • In addition, excellent interpersonal skills with strong organizational skills and an attention to detail are needed
  • Must be computer literate and be able to travel depending on project needs
6

Pr Clinical Research Specialist Resume Examples & Samples

  • Bachelor’s degree required, preferably in a technical (health, science, or engineering) field
  • 7 or more years of experience in a regulated industry (preferably involving medical devices) with a Bachelor’s Degree
  • 5 or more years of experience with a Master’s, with at least 5 years in Clinical Affairs
  • Demonstrated knowledge of U.S. regulations for medical devices or a related regulated industry, particularly regulations and industry standards pertaining to clinical investigations
  • Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians, executive management, and cross-functional teams and individuals
  • Excellent office computer skills (email, word-processing and spreadsheet software, clinical databases)
  • Effective cross-functional team player with ability to work in a team environment and exert influence without alienating others
  • Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity
  • Experienced in setting and driving clinical research strategies
  • Experience with regulated research including regulatory authority submissions and process for IDE, PMA, 510(k), and CE marking
  • Experienced in serving on product development teams and understands the product development lifecycle
  • Advanced understanding of Clinical, Regulatory and Quality systems
  • Demonstrated scientific aptitude for medical and anatomical terminology, medical therapies and literature, and hospital/clinical environments
  • Fundamental understanding of international device regulations and industry standards
7

Senior Clinical Research Specialist Resume Examples & Samples

  • Bachelor degree (minimum)
  • Bachelor degree with 5+ years of relevant experience
  • Graduate or advanced degrees with less experience may be considered
  • Experience translating medical industry needs and knowledge to product opportunities
  • Knowledge of applicable regulations and standards for medical devices and clinical research
  • Computer literate with above average knowledge of Microsoft Office applications Outlook, Word, Excel and Microsoft Project software
  • Detail oriented and well organized
  • Good teamwork skills
  • Able to read and interpret technical procedures and regulatory requirements
  • Able to work effectively on a cross-functional team
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers via a variety of media including telephone, email, instant message, social networking platforms, and in-person meetings
  • Role requires frequent travel, up to approximately 45%
8

Associate Clinical Research Specialist Resume Examples & Samples

  • Bachelor degree in biological or health sciences
  • 1+ years clinical study experience in medical device of pharmaceutical field
  • Ability to recognize problems and take corrective measures
  • Ability to monitor and audit clinical data, clinical sites, and study related activities
  • Ability to assist in the development of operating procedures for clinical investigations
  • Familiarity with ISO 9000, EN 46000, Medical Device Directive (EC), Code of Federal Regulations (U.S)
  • 1+ years of experience in Medical Device
  • Neurology experience is a plus
9

Clinical Research Specialist Resume Examples & Samples

  • Assess subject’s history and physical for suitability for inclusion in research projects. Obtain study specific informed consent from eligible subjects after detailed description of study requirements, risks and benefits, and follow up with all subject questions answered in accordance with FDA, HIPAA and ICH GCP guidelines
  • Develop and maintain a relationship with study subjects, physicians and their office staff to promote study compliance, follow-up and collection of possible adverse events
  • Maintain effective communication with patients, physicians, and the company representative or clinical monitor for each research protocol, including education of nursing staff or other participants
10

Clinical Research Specialist Resume Examples & Samples

  • Participate in the evaluation of research protocols including study design and risk to target population. Assist in determining facility and equipment availability. Assess target population/availability
  • Participate in protocol development and budget development as needed. Access and extract information for protocol development. Assist with composition and preparation of regulatory/IRB documents for new study submissions, amendments, continuing reviews and close-out. Develop worksheets for standard of care versus study specific procedures
  • Schedule and/or coordinate study-related meetings, training sessions and pre-study site visits of sponsors. Develop advertising and other information materials for recruitment. Recruit subjects according to IRB-approved protocols. Schedule study visits, complete all necessary pre-visit tasks and execute study procedures according to protocols and clinical needs. Consent subjects and ensure that the Informed Consent Process is conducted appropriately and all forms are properly signed before the start of the study. Develop and implement teaching tools for subjects and families. Serve as advocate for the subjects and their family
  • Order and receive drug/device supplies for studies and maintain appropriate inventory. Manage regulatory records for all medications and devices, including but not limited to logs for medication, dispensing logs, dates of expiration and refrigerator logs. Assist in preparation of drug orders. Oversee the proper handling of laboratory specimens including processes, shipping, storage, and documentation. Assist in assignment of drug and/or device supplies to research subjects
  • Create source documentation tools. Extract data from source documents to complete Case Report Forms (CRF) and database entries. Collaborate with providers in the collection of clinical data. Audit for accuracy. Resolve sponsor queries to CRFs and regulatory documents
  • Communicate with research subjects and hospital personnel to obtain follow-up information as needed. Review incoming subject adverse event (AE) information and assist PI in making submission and/determination of AEs. Capture and record adverse event data and compose reports for oversight agencies
  • Conduct study-related and clinical-related assessments. Monitor for protocol compliance; document and report protocol deviations. Document patient responses to all interventions. Communicate with Principal Investigators regarding changes in protocols. Prepare and manage monitor visits. Maintain study documents as required by Regulatory guidelines. Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings
11

Clinical Research Specialist Resume Examples & Samples

  • Responsible for the submission of all regulatory paperwork required for each clinical research study
  • Recruit subjects according to IRB protocols
  • Consent subjects
  • Assist with budget development
  • Identify and schedule screening procedures and review results
12

Clinical Research Specialist Resume Examples & Samples

  • Be willing to travel across in NC and SC with an average of 1 trip/month
  • Excellent Communication Skills and the ability to work with a multi-disciplinary research team
  • Must be flexible and comfortable interviewing physicians, nurses, and patients
  • Previous regulatory experience preferred
13

Clinical Research Specialist Resume Examples & Samples

  • Develop, submit and track human subject applications. Identify and schedule screening procedures and review results. Be available to travel domestically to site locations up to 4 times a year
  • Oversee preparation of documents required for submission to IRB. Compose and supervise preparation of regulatory documents including updates to Informed Consent forms
  • Monitor and ensure study team compliance with protocol and SOPs. Record, document and report protocol deviations
  • Develop programming surveys online
  • Construct and maintain databases. Extract data from source documents. Prepare preliminary reports from databases
  • Provide/create source documentation tools for subject’s charts/records. Develop and implement teaching tools for subjects and families
  • Assist with professional and academic publications, conference presentations, and reports
  • Conduct weekly meeting with investigators. Work with investigators and other team members to develop solutions to complex problems that may impact the timely and accurate conduct of the study. Train and support personnel on study-specific tasks
14

Clinical Research Specialist Resume Examples & Samples

  • Assist in the preparation of study documents including IRB application, SOPs and Informed Consent. Determine the eligibility of patients for protocol then register and/or randomize for entry on study. Explain study requirements and procedures including Informed Consent forms. Verify with the Research Nurse or physician that Informed Consent form has been obtained prior to registering the patient to the study
  • Recruit adolescent participants, administer quantitative surveys, and conduct qualitative interviews. Interview study patients to procure information required by protocol which is not typically captured in the physician or nurse interaction. Instruct patients on the completion of patient diaries or questionnaires which document their experience in the research study
  • Provide additional information on contraception as requested by study participants. Construct patient consent forms to comply with federal and local IRB guidelines governing the use of human subjects. Submit clinical research protocols and serial amendments to the IRB for review and approval. Prepare for regulatory agency audit by maintaining communication regarding the status of the study, securing source documents, reviewing case reports for accuracy and completeness, and resolving any discrepancies with auditors
  • Train and supervise part-time student research assistants in study procedures
  • Conduct advisory board meetings
15

Clinical Research Specialist Resume Examples & Samples

  • Performing data collection through patient chart review, maintaining databases, obtaining participation consent and other forms from patients
  • Plan and design experiments in conjunction with senior investigators, participate in protocol development, IRB submissions, data analysis, generate result reports, draft abstracts and manuscripts
  • Participate in research meetings, coordination with other research staff and collaborators
16

Clinical Research Specialist Resume Examples & Samples

  • Design recruitment strategies, recruit potential subjects, determine subject eligibility, and consent subjects according to the IRB/protocol approved methodologies. Develop advertisement and other information materials for recruitment. Track (locate subjects and maintain database of subject’s contact information using written, phone, computer and social media) and recruit subjects from an established pool of families who participated in previous phases of current study. Perform subject interviews and study-related simple medical/behavioral assessments and neuropsychological battery testing assessments. Train with senior staff on conducting psychiatric diagnostic interviews
  • Determine appointments per protocol. Schedule and/or call subjects for appointments and follow-up visits. Assist in the conduct of study-related, simple medical/behavioral assessments, perform study interview and testing. Follow-up with research participants to determine the completion of self-reporting assessments and answer subject questions. Collect and process bio-specimens per laboratory manual instructions. Obtain medical records according to HIPAA guidelines, and file appropriately
  • Set up files, both electronic and paper (binders) for subject data. Enter data from assessments using computerized data entry programs. Collect and file completed self-report questionnaires in subject binders. Summarize and provide information for reports to the research team for internal meetings, the IRB, and study sponsor. Work with data manager to maintain and update data bases and prepare reports as needed. Complete case report forms and enter into database. Run database error reports during analysis. Address and resolve queries/errors discovered during analysis
  • Record, document and report protocol deviations and adverse events. Communicate with PI/CO-I/project manager on issues. Maintain updated enrollment log for primary study and sub-studies. Create agenda for team meetings. Process subject payments per completion of assessments
17

RN Clinical Research Specialist Resume Examples & Samples

  • Promotes research study initiation and review. Acts as the project representative and professional resource for coordination of staff, sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. Reads and evaluates clinical research protocols. Attends departmental, committee, and sponsor meetings for the purpose of gathering new or revised information concerning existing or potential clinical research projects
  • Performs accurate data collection and reporting according to protocol requirements and completes applicable forms and/or other required reports in a timely manner. Facilitates and conducts site reviews with sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data. Develops and implements patient tracking and follow-up systems. Coordinates with participating physicians offices and staff for patient follow-up
  • Assists in educating patients about research studies and in obtaining informed consent from project participants. Develops and maintains educational tools, educates research team members and assists staff in the conduct of the investigational therapy. Performs medical record reviews. Assists with patient recruitment, screening, diagnostics, treatment and education. Utilizes clinical knowledge and assessment skills necessary to evaluate, report and record accurate medical information, including responses to therapy
  • Participates in the development of clinical research protocols. Performs accurate and timely data collection and reporting according to protocol requirements. Facilitates and conducts site reviews by sponsors and other related agencies for the purpose of monitoring the accuracy and quality of the collected data. May hire, train, conduct performance reviews, and direct the workflow for the department staff
18

Clinical Research Specialist Resume Examples & Samples

  • Recruit subjects according to IRB/Protocol approved methodologies. Assist in assessment of study population/availability. Develop advertisement and other information materials for recruitment. Consent subjects and ensure that Informed Consent forms are properly signed before the start of the study
  • Schedule appointments with subjects per protocol visit window schedules. Create source documents for protocol visits. Obtain source data at visits. Perform phlebotomy as needed. Extract data from source documents. Complete case report forms. Capture and record adverse event data. Compose adverse event reports. Contact outside health-care providers and subjects to obtain follow-up information. Assist in resolving sponsor queries
  • Compose and submit continuing review/amendments/close out information. Record, document, and report protocol deviations
  • Oversee proper handling of laboratory specimens including processes, shipping, storage, and documentation
19

Clinical Research Specialist Resume Examples & Samples

  • Will assist in soliciting industry-sponsored trials through contacts and professional organizations. Summarize literature review for study hypothesis. Assist in resolving sponsor queries. Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development for medical library and online databases. Participate in protocol development or review of risk assessment for investigator-initiated trial or sponsor studies. Assist in determination of staff availability and assessment of study population/availability. Participate in the preparation and negotiation of study budget. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreement. Assist in developing advertisement and other information materials for recruitment
  • Compose and supervise preparation or modification of regulatory documents including updates to Informed Consent forms submitted to IRB. Identify and schedule screening procedures and review results as required by study protocol. 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 and/or call subjects for appointments. Coordinate subject visits with support services. Contact outside health-care providers to obtain follow-up information. Communicate with subjects to obtain follow-up information. Assist in developing and implementing teaching tools for subjects and families. Train support personnel on study-specific tasks. Serve as an advocate for the subjects and their family. Review incoming subject adverse event (SAE) information and assist PI in making submission and/determination of SAEs. Capture and record adverse events data. Compose adverse event reports for oversight agencies. Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meeting
  • Recruit subjects and collect samples according to IRB/protocol approved methodologies
20

Principal Clinical Research Specialist Resume Examples & Samples

  • 7+ years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance
  • MS, MA, MPH, PharmD, PhD, DVM, or MD with 6+ years experience supporting clinical research
  • Pre-market clinical experience (IDE or IND)
  • MS, MA, MPH, PharmD, PhD, DVM, or MD with 6+ years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance
  • Minimum of 3 years in study management
  • Minimum of 1 year monitoring experience
  • Significant knowledge of clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals
  • Protocol development experience
  • IDE/IND submission experience
  • Previous audit experience
  • Demonstrated ability to maintain regulatory compliance
  • Experience working with Microsoft Word, Excel, PowerPoint and familiarity with web-based applications
  • Experience in a wide variety of study phases including study start-up and study closure
  • Demonstrated ability to clearly and effectively communicate verbally and in writing
  • Proficient use of project management tools
  • Demonstrated ability to define strategic direction for clinical evidence that is in alignment with business priorities and product planning strategies and incorporates global perspectives
  • Demonstrated ability to perform systemic analysis and make timely and well-reasoned decisions based on an insightful analysis of all critical information and the pros and cons of alternatives; ability to balance analysis with decisiveness
  • Demonstrated ability to develop innovative and well-planned business, product, and clinical strategies that optimally position products for approval and/or provide critical clinical evidence for existing products on the market
  • Demonstrated ability to identify problems and implement solutions in addressing issues within business strategies, product planning or clinical strategies
  • Ability to maintain composure in difficult circumstances
21

Clinical Research Specialist Resume Examples & Samples

  • Preparing patient case studies detailing the patient’s medical history, current disease staging and consequences of research treatment both side effects and disease response
  • Construct patient consent forms to comply with federal and local IRB guidelines governing the use of human subjects
  • Instruct patients on the completion of patient diaries or questionnaires which document their experience in the study
  • Interview study patients to procure information required by protocol which is not typically captured in the physician or nurse interaction
  • Will maintain a computerized master registry for storage and retrieval of protocol and patient specific information
  • Provide patient care needed as described in all applicable standards, and appropriate to the age and developmental level of the patients served
22

Principal Clinical Research Specialist Resume Examples & Samples

  • Experience managing clinical trials from start to finish
  • Previous personnel management and/or previous experience providing work direction to staff and accomplishing study execution through others
  • Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals
  • Experience facilitating committees (e.g. Clinical Events Committee, Data Safety Monitoring Board, Adverse Events Advisory Committee, etc.) and/or managing vendors (e.g. Contract Research Organizations, Core Laboratories, etc.)
  • Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
  • Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
23

Clinical Research Specialist Resume Examples & Samples

  • Conduct clinical trials in the section of Hematology/Oncology. Identify potential research subjects for ongoing trials (therapeutic/non therapeutic). Determine/verify patient eligibility per study requirements and ensure appropriate consents are obtained for the clinical trial. Collect and evaluate the study data and submit data reports to sponsors/principal investigators including treatments and assessment of adverse events. Collect and process specimens according to clinical trial
  • Ensure compliance with study schedules and data submission. Prepare and document protocol deviations as required by sponsor and IRB. Monitor investigatory drug dispensing. Develop tools for collecting and maintaining study data and documents to ensure compliance of federal guidelines for clinical research. Train and educate department staff of the scientific and study specific requirements. Develop database for specimen bio-bank requirements. Assemble reports for granting agencies
  • Prepare/submit institutional review board documents and regulatory documents for sponsors. Evaluate and prepare budget/billing documents for the trial. Coordinate site visits and monitoring visits with sponsors. Work with financial staff to determine study versus standard of care procedures for study billing compliance
  • Audit internal documents for accuracy and compliance with good clinical practice. Prepare study documents sponsor or regulatory agency audits or monitoring visits
24

Clinical Research Specialist Son Resume Examples & Samples

  • Provide telephone-based Willams Life-Skills Cancer Caregiver training to caregivers in the pilot study
  • Recruitment and consent of research subjects a. In collaboration with clinic providers, identify patients who meet study eligibility criteria and are scheduled to visit the Duke Cancer Clinic between February and July 2017. b. Mail recruitment letters to identified patients identified as described above. c. Recruit patients and caregivers at the Duke Cancer Clinic who will not call the study phone number to opt out of study participation. d. Brainstorm with the PI about new ways to recruit and retain research participants e. Prioritize, coordinate and track contact with potential subjects as well as new and currently-enrolled study participants f. Conduct and document consent within the approved IRB process including documentation of consent, notice of private practice documentation and storage of consents
  • Data Collection a. Participate in the development of study forms, questionnaires and study procedures (SOPs). b. Collect required study data which could include surveys in person and by telephone. c. Ensure all data collected is captured, collected and stored in the approved IRB and Duke required practice. d. Keep and maintain detailed records of where each subject is in the study timeline, and relevant lost subject/withdrawn data when applicable. e. Provide enrollment counts to PI when requested, as well as counts for how many subjects have completed each time point in the study. f. Schedule (and re-schedule when necessary) and confirm appointments g. Prepare materials for each session
  • Communication/Reports a. Provide requested information about enrolled subjects to PI and study staff and facilitators b. Alert PI to potential issues where it is not clear how to proceed (i.e., situationsthat are out of the ordinary) c. Participate in conference calls with collaborators at outside institutions regarding material revisions and standard procedures for the study d. Assist collaborators and statisticians in understanding data discrepancies Check manuscripts and papers written using the data collected to ensure the figures reflect study records
  • Organization a. Ensure that all study materials used are the ones approved by the IRB on the eIRB website. b. Keep study documents and materials up to date on the SED drive c. Assist the PIs in requesting new SED folders for new studies d. Assist PIs in proofing new study materials and suggesting modifications in wording or order, providing feedback based on previous contact with research subjects and materials e. Create and maintain filing systems and study logs for new studies. Label and instruct other study personnel how to find files and materials
  • Database management a. Coordinate and assist with database data entry. a. Facilitate communication with database specialists to create tracking databases and survey databases for new studies b. Maintain study databases and ensure they are up-to-date at all times. c. Assist with data coding, working closely with statisticians for data clean up and preparation for statistical analysis
  • Miscellaneous a. Follow Duke procedures in regards to collecting IRB Data Disclosure form and requirements around SSN# storage and payment processing. b. Perform other related and requested duties incidental to the work described herein. c. Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers)
25

Clinical Research Specialist Resume Examples & Samples

  • Licensed as a Registered Nurse in the Commonwealth of Massachusetts
  • Master's degree in nursing
  • Minimum of 3-5 years recent experience as a nurse in oncology
  • Leadership and education experience required
  • Appropriate advanced practice nursing certification
  • Clinical expertise in oncology nursing
  • Ability to work as an effective member of an interprofessional team
  • Excellent organizational, communication and interpersonal skills
  • Program or project development experience
  • Critical thinking and problem solving skills
  • Ability to make independent decisions
  • Identifies personal, clinical and leadership strengths and areas for growth, formulating professional goals, objectives and methods for accomplishment
  • Compliance with accepted standards of professional nursing practice and all licensure and registration requirements applicable to the nursing role
26

Clinical Research Specialist 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
  • Follow up/ Schedule study subjects. Perform study interviews. Conduct study-related clinical procedures and interventions. Ensure proper collection, processing, and shipment of specimens. Review serious adverse events. Collaborate with physicians and other care givers in the collection of clinical data. Monitor for protocol compliance. Prepare for and manage monitor visits. Understand and follow IRB guidelines. Educate staff regarding scientific aspects of the study
  • 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 subjects’ 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)
27

Clinical Research Specialist Resume Examples & Samples

  • Scientific concepts and research design. Conduct literature reviews under the direction of the CRC, CRNC, or PI
  • Leadership and professionalism. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements
  • Study and site management. Prepare items for site initiation visits. Participate in sponsor required training
28

Clinical Research Specialist Resume Examples & Samples

  • Conduct clinical trials in the section of Clinical Translational Research. Identify potential research subjects for ongoing trials (therapeutic/non therapeutic). Determine/verify patient eligibility per study requirements and ensure appropriate consents are obtained for the clinical trial. Collect and evaluate the study data and submit data reports to sponsors/principal investigators including treatments and assessment of adverse events. Collect and process specimens according to clinical trial
  • Ensure compliance with study schedules and data submission. Prepare and document protocol deviations as required by sponsor and IRB. Monitor investigatory drug dispensing. Develop tools for collecting and maintain study data and documents to ensure compliance of federal guidelines for clinical research. Train and educate department staff of the scientific and study specific requirements. Develop database for specimen bio-bank requirements. Assemble reports for granting agencies
  • Audit internal documents for accuracy and compliance with good clinical practice. Prepare study documents for sponsor or regulatory agency audits or monitoring visits
29

Clinical Research Specialist Resume Examples & Samples

  • Regulatory Coordination, i.e. prepare initial regulatory documents and update them as needed; Create and maintain regulatory binder and/or electronic files; Route regulatory documents for signature
  • Coordinator and communication, i.e. Schedule and coordinate site evaluation visits; schedule study related meetings and training sessions; ensure proper documentation of study
  • Data Management, i.e. Review incoming subject SAE information and assist in submission of SAE and compose SAE reports
30

Clinical Research Specialist Resume Examples & Samples

  • Participate in protocol review, evaluations, study design and risk assessments to subject population; participate in study budget negotiations and reconcile study budget accounts with Business Manager; review, evaluate and comment on study contracts/agreements; prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, Amendments, Continuing Reviews, and study close out); develop informational materials for recruitment; organize and distribute regulatory documents; assess study population/availability; provide/secure source documentation tools for subjects’ charts/records (familiarity with OnCore is a plus); communicate with PI and sub-investigators about changes in trial, commonly by teleconference or videoconference; must be capable of communication/interaction with the public, patients and medical staff. Ideally, function as an extension of the PI for clinical research related activities
  • 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 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 on various platforms (experience with industry eCRFs as well as REDCap is a plus); order and receive drug/device supplies as directed; capture and record adverse event data; manage handling and processing of laboratory specimens; maintain 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, preparing study folders for multiple studies, arranging meetings, and data entry; work in a team environment with a professional and positive attitude; at times, supervise and manage part time research staff, full time research assistants, residents, students, and volunteers; 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
31

Clinical Research Specialist Resume Examples & Samples

  • Submission of all regulatory paperwork required for each clinical research study
  • Recruit subjects according to IRB protocol and consent subjects
  • Assist with budget development
  • Contact outside health-care providers to obtain follow-up information
32

Clinical Research Specialist Resume Examples & Samples

  • Manage the documentation and completion/renewal of required IU and VA trainings for new and current personnel or practicum students. Train support personnel on study-specific tasks. Administer interview based assessments including, but not limited to, the Positive and Negative Syndrome Scale and the Quality of Life Scale
  • Prepare documents related to and manage custodial fund. Maintain payee certification receipts and submit coinciding Disbursement Voucher(s) and paperwork for research participant payment. Keep log of participant payments and dates. Send reconciliation form monthly to IU. Management of payment vouchers in concurrence with VA policy and communicate when required for replenishment of payment vouchers
  • Extract data from source documents. Compete Case Report Forms (CRF) or database entries. Manage study databases. Enter data from participant assessments into study database. Administer manualized group interventions that address stigma reduction
  • Assist in developing advertisement and other information materials for recruitment. Identify and schedule screening procedures and review results. 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
33

Clinical Research Specialist Resume Examples & Samples

  • Bachelor’s Degree in Project Management, Organizational Management
  • Experience using multiple software programs and spreadsheets
  • Bachelors degree in clinical or scientific related field
  • Setting up projects with the Customer Support and Monitoring Centers
  • Developing materials for projects
  • Performing the order process for projects
  • Tracking inventory and invoicing
  • Basic troubleshooting with Customer Support and Customers
  • Providing monthly forecasting for each project
  • Developing and conducting training for Sponsors and Sites
34

Clinical Research Specialist Resume Examples & Samples

  • Reviews and evaluates the adequacy and effectiveness of internal control systems through monitoring and auditing
  • Verifies the investigator has adequate qualifications and resources to support that facilities (including laboratories, pharmacy, and patient treatment centers) equipment and staff are adequate to safely and properly conduct the trial
  • Confirms the investigator follows the approved protocol and all approved amendment(s)
  • Validates that written informed consent was appropriately obtained before each subject’s participation in the trial
  • Verifies that the investigator is enrolling only eligible subjects
  • Determines whether all adverse events and deviations are reported to the appropriate departments/offices/agencies within the time periods required
  • Confirms whether the investigator is maintaining the essential documents
  • Verifies data collected is accurate and reflects source documentation
  • Analyzes the processes under review and assesses applicable revisions in the process
  • Gathers evidential matter to support findings, conclusions, and recommendations. This includes, but is not limited to, documentary evidence as well as analytical, compliance, and substantive testing
  • Uses information or data effectively to persuade others or to support a viable position
  • Participates in planning, conducting, and results reporting of scheduled audits, special projects and/or investigations assigned by the Director, Internal Audit
  • Performs administrative duties pertaining to audits performed, including documentation of findings along with proposed action plans, reports and formal presentations to management
  • Develops and maintains relationships with management and staff in order to create a favorable relationship with and good understanding of the audit function, while remaining independent and
35

Clinical Research Specialist Resume Examples & Samples

  • Leadership and professionalism. Recognize and employ the professional guidelines and code ofethics related to the conduct of clinical research. Maintain Duke andproject specific training requirements
  • Study and site management. Prepare items for site initiation visits.Participate in sponsor required training
  • Communication and team science. Participate in study team meetings.Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.Perform other related duties incidental to the work described herein.The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified
36

Prin Clinical Research Specialist Resume Examples & Samples

  • 7+ years experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable OR MS, MA, or MPH with 5+ years experience or PharmD, PhD, DVM, or MD with 3+ years experience supporting clinical research
  • Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field
  • Experience managing cardiovascular medical device and/or pharmaceutical trials
  • 3+ years of previous study management
  • Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field)
  • Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers
  • Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
  • Willingness to accept challenging assignments and engage in relevant developmental activities
  • Exceptional project management capabilities and proficient use of project management tools
37

Senior Clinical Research Specialist Resume Examples & Samples

  • 4+ years experience directly supporting clinical research or research experience in medical/scientific area
  • Working knowledge of Good Clinical Practice (GCP) and regulations for clinical trials
  • High attention to detail and accuracy
  • Ability to manage multiple tasks in a fast-paced environment
  • Project management skills
  • Proficient knowledge of medical terminology
38

Senior Clinical Research Specialist Resume Examples & Samples

  • 4+ Years of Clinical Research Experience
  • Bachelor’s degree in Project Management, Organizational Management, Pharmaceutical/Scientific Discipline, clinical or scientific related field
  • Experience conducting clinical trials with medical devices and/or pharmaceutical’s
  • Experience conducting global clinical trials (Japan, China, Australia, South America and India are a plus)
  • Experience working with vendors/CRO’s
  • Experience managing multiple projects
  • Excellent planning and organizational skills with effective negotiation skills, time management and people skills
39

Clinical Research Specialist Resume Examples & Samples

  • Scientific concepts and research design. Conduct literature reviews under the direction of theCRC, CRNC, or PI
  • Leadership and professionalism. Recognize and employ the professional guidelines and code ofethics related to the conduct of clinical research. Maintain Duke and project specific training requirements
  • Study and site management. Prepare items for site initiation visits.Participate in sponsorrequired training
  • Communication and team science. Participate in study team meetings.Respond to routine questions related to study protocol and refer more complex questions toothers as appropriate.Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively
40

Clinical Research Specialist Resume Examples & Samples

  • Responsible for recruitment for open clinical trials
  • Plan and implement recruitment strategies
  • Research appropriate venues for study advertising
  • Respond to study inquiries
  • Conduct phone screens of potential subjects
41

Clinical Research Specialist Resume Examples & Samples

  • Conduct and manage four interventional study arms
  • Maintain and manage study equipment, including troubleshooting/monitoring of subjects’ study computers
  • Communicate with subjects to obtain follow-up information
  • Complete Case Report Forms (CRF) and database entries
  • Assist in assessment of study population/availability
  • Recruit subjects according to IRB/protocol approved methodologies
  • Consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent is obtained prior to study procedures
  • Determine staff and facility/equipment availability
  • Capture and record adverse events data
  • Assist in resolving database queries
  • Access and extract information for protocol development/amendment
42

Clinical Research Specialist Resume Examples & Samples

  • Independently manage clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management
  • Independently monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance; occasional handling of biological samples may be required, based upon project need
  • Assist clinical sites with IRB submission / documentation, as needed
  • Utilize a working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
  • Anticipate and identify problems / issues and implement resolutions or provide recommendations for corrective actions in relevant job areas
  • Work cross-functionally with Regulatory Affairs and Quality Management, as workload permits, to support efforts in these areas
  • BS/BA in life science discipline or equivalent combination of education and experience
  • Demonstration of 8-10 years of successful experience in related field and successful performance of responsibilities presented above
  • CCRA certification with ACRP or SoCRA
  • Experience in in vitro diagnostics and/or the medical device industry
  • Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
  • Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
  • Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically; <10% internationally
  • MT/MLT or equivalent
  • Experience with clinical trials involving hemostasis and/or urinalysis analyzers
  • Experience with Pre-Subs and 510k submissions
43

Clinical Research Specialist Resume Examples & Samples

  • Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution
  • Responsible for specific and assigned aspects of research infrastructure development and/or maintenance
  • Coordinates research projects at an institutional or departmental level
  • Communicates project status and improvement areas with leadership in a timely manner and approaches and communicates improvement areas in a solution-based manner
  • Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report from development, budget development, and coordination of departmental research committees
  • Provides guidance regarding project planning, project logistics, and project implementation
  • Serves as an internal consultant for specific departmental activities
  • Provides research writing activities such as, developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols
  • May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts
  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA)
44

Clinical Research Specialist Resume Examples & Samples

  • Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements
  • Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded
  • Home site within the Mid-West United States territory
  • Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
  • Ability to travel up to 75% supporting Mid-West US Territory
45

Clinical Research Specialist Resume Examples & Samples

  • Responsible for the submission of all regulatory paperwork required for each clinical research study. 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
  • Assist with budget development, invoicing for adverse events, billing compliance and patient billing resolution
  • Identify and schedule screening procedures and review results. Assist in the preparation for monitoring visits
  • Monitor and ensure study team compliance with protocol and SOPs. Record, document, and report protocol deviations. Communicate with PI and sub-investigators about changes in the trial
  • Contact outside health-care providers to obtain follow-up information. Communicate with subjects to obtain follow-up information
  • Develop advertising and other information materials for recruitment
46

Clinical Research Specialist Resume Examples & Samples

  • BS/BA/RN and/or MS/MSN degree in science or a health related field
  • 3-5 years of experience working with medical devices or healthcare in a clinical research management role
  • Ability to collaborate in a team environment
  • Ability to execute tasks quickly and with meticulous accuracy and consistency
  • Proficiency in using Microsoft Office programs, including, but not limited to, Word, Excel, PowerPoint, Outlook
  • Knowledge of research methodology (including clinical investigation design and biostatistics)
  • Knowledge of information management
  • Knowledge of GCP and FDA regulations
  • Knowledge of clinical research regulations, guidelines and compliance including IRB
  • Understanding and experience with statistics
  • Experience with medical writing
  • Experience conducting systematic literature searches
  • Ability to understand and interpret statistical results of clinical studies and understand good data management practices
  • Certified Clinical Research Associate (CCRA) credential
  • Understanding of MDD requirements
  • Demonstrated knowledge and experience in clinical research, quality regulatory compliance and adverse event reporting
  • Experience within the medical device industry and knowledge of clinical evaluation reporting and regulatory requirements
  • Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane)
47

Clinical Research Specialist Advanced Resume Examples & Samples

  • Bachelors degree with major study in nursing or an academic field related to the health sciences, or equivalent experience
  • Significant clinical experience
  • Experience supporting, facilitating, and carrying out qualitative and/or quantitative human study research projects
  • Experience recruiting, screening and interviewing human research participants
  • Experience with various methods of data collection
  • Experience developing human subject research project standard operating procedures, policies and guidelines
  • Experience maintaining and auditing research study records in compliance with the IRB
  • Experience tracking and establishing statistical data using statistical software
  • Demonstrated ability to engage with a large and diverse peer group, as well as excellent written and verbal communication skills
  • Ability to work in a diverse environment
48

Clinical Research Specialist Resume Examples & Samples

  • Database experience
  • Medical record experience
  • Ability to work both individually and as part of a team
  • Cerner and Careweb Experience
  • Writing skills
49

R&D Clinical Research Specialist Resume Examples & Samples

  • Initiate clinical research for Arthrex sponsored studies
  • Associate’s degree required
  • 4 years relevant experience required
  • Experienced in record keeping using excel or other suitable programs
  • Familiarity with orthopedics is advantageous
50

Clinical Research Specialist Resume Examples & Samples

  • May be required to travel to Investigator's meetings and/or Study Coordinator training meetings, as assigned. Frequency varies between 1 to 3 offsite meetings per year may be possible
  • Manages recruit, screenings, determines eligibility of patients, ensure informed consent is properly secured and documented and obtains patient medical history for various clinical trials
  • Coordinating and conducting all aspects of study visits with patients. Manages patient care in compliance with the research study or clinical trial protocol requirements. Monitors subject condition while ensuring safety and maintaining confidentiality
  • Coordinate complex research study or clinical trial data. Develop methods for collection, source documents, database storage, tracking, analysis, and interpretation of data. Develop 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
  • Maintain IRB submissions, protocol amendments, reportable new information reports,and renewals on multiple clinical trials at a time
  • Maintain Regulatory Binders and adhering to regulatory requirements. Conduct quality assurance audits on data and regulatory documentation
  • Coordinate and conduct study site qualification visits, site initiation visits, and monitoring visits. Attend research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities
  • Schedule study procedures with radiology, pulmonary function, General Clinical Research Center (GCRC) and other ancillary services
  • Process blood or other bodily fluid specimens, clinical procedures such as (but not limited to): basic spirometry,6 Minute Walk Tests (6MWT),aerosol drug delivery, induced sputums procedures for study
  • Possesses a knowledge of data manipulation and analysis and clinical research procedures and able to perform position in compliance with all requirements, regulations, and 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. 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 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. Skills in ethically communicating risks and benefits an 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
51

Clinical Research Specialist Resume Examples & Samples

  • Coordinate all aspects of funded pediatric clinical studies
  • Preparation, review submission and tracking of IRB documents
  • Recruit, screen, consent and collect data for multiple concurrent studies
  • Use REDCap and other database systems for data collection, tracking of study documents and participants
52

Clinical Research Specialist Resume Examples & Samples

  • 30% Study Initiation
  • Assist in soliciting industry-sponsored trials and grants through contacts and professional organizations
  • Participate in the evaluation of the protocol, study design, and risk to subject population
  • Assist in determination of staff availability and assessment of study population/availability
  • Participate in the preparation and negotiation of study budget and assist in the design of OnCore Calendars and Financials. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreements
  • Prepare and submit Institutional Review Board documents (i.e. Informed Consent, advertisement, protocol, and protocol summary). Prepare regulatory documents for sponsor or grant as needed
  • Schedule and coordinate pre-study site visits with sponsors
  • 40% Study Conduct
  • Recruit subjects according to IRB/protocol approved methodologies. Develop advertisement and other information materials for recruitment as needed. Monitor enrollment goals and modify recruitment strategy as needed
  • 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
  • Extract data from source documents. Complete Case Report Forms (CRFs) or database entries
  • Assist in resolving sponsor or investigator queries
  • Oversee the proper handling of laboratory specimens as needed including processes, shipping, storage, and documentation
  • Enter subject, research billing, and necessary study related information into OnCore in a timely and accurate manner
  • 30% Study Monitoring
  • Capture and record adverse events data. Compose adverse event reports for oversight agencies
  • Schedule study-related meetings and training sessions. Provide instruction to study team for specific study assignments. Educate staff regarding scientific aspects of the study. Train ancillary staff regarding clinical trial and grants as needed
  • Compose and submit continuing review/amendments/close out information
  • Assist in preparation for monitoring visits
  • Monitor and ensure study team compliance with protocol and SOPs. Record, document, and report protocol deviations. Communicate with PI and Clinical Research Administrator about changes in the trial
  • Reconcile study budget accounts with department financial manager
  • Experience with Excel is very useful
53

Clinical Research Specialist Resume Examples & Samples

  • Assists with the preparation, submission and management of internal/external compliance documentation at all stages of the research project
  • Assists with the selection, education, testing, and monitoring of research project participants. Follows protocols and collaborates with other healthcare providers to ensure continuity of participant care
  • Documents patient care and study results using appropriate formats and systems. Communicates patient/study results on an on-going basis to research team
  • Participates in quality assurance/improvement initiatives. Ensures compliance with applicable standards of care and regulatory requirements
  • All other duties as assigned
54

Senior Clinical Research Specialist Resume Examples & Samples

  • Prepare and revise study materials and/or training
  • Conduct training of site and/or Medtronic staff
  • Assist in site initiation activities (e.g. study start-up documentation preparation)
  • Set-up and maintain accurate progress and study status tracking logs
  • Assist in the preparation of reports, regulatory submissions, publications and presentations
  • Assist in the preparation of budgets and project plans
  • Identify and mitigate quality risk and/or issues associated with assigned studies/activities
  • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines
  • 4+ years’ experience in clinical research (Master’s degree will substitute for 1 year experience)
  • Strong knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies
  • Computer skill competency (MS Office products, spreadsheets, power points, etc.)
  • Ability to work well within teams, build relationships
  • Good prioritization and organizational skills, able to manage multiple tasks
  • Strong communication skills (efficient, effective, transparent)
55

Principal Clinical Research Specialist Resume Examples & Samples

  • Provides project and study management and assures successful conduct of assigned clinical studies/projects
  • Drives process to determine study/project objectives, strategy, scope, and schedule in order to meet business needs
  • Develops the required clinical/project documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan, CERs) in consultation with the cross-functional team, investigators, and the clinical team
  • Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes
  • Establishes selection criteria for principal investigators and investigative sites and drives center selection process
  • Responsible for site identification, qualification, initiation, training to ensure study compliance and subject protection
  • Assures training of investigators, center staff and Medtronic clinical staff
  • Ensure accurate inventory accountability of investigative product at clinical sites
  • Facilitates meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees
  • Supports and may interact as the clinical representative with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings, regarding requirements and results of the study
  • Enlists support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team
  • Critically evaluates clinical data/information and prepares interim and final reports
  • Performs risk analysis and develops contingency plans for successful study implementation
  • Develops study budget and manages study spending to plan
  • Develops a cohesive, high-functioning team by providing feedback, mentoring, and performance management input for clinical study team members
  • Ensures site activities in alignment with study milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans, as needed
  • Responsible for accurate and timely adverse event reporting during the study
  • Will ensure site adherence to FDA, ISO, local regulatory, IRB/EC and Medtronic requirements
  • Work with investigators to quickly and effectively resolve problems
56

Senior Clinical Research Specialist Resume Examples & Samples

  • Languages: French and English fluent; another European language a plus
  • Ability to work autonomously with a direct line manager based in French speaking Switzerland
  • While performing the duties of this job, the employee is regularly required to be independently mobile
  • The employee is also required to interact with a computer, and communicate with peers and co-workers
  • Ability to read, participate in telephone conferences and sit for meetings
  • Ability to use a computer for extended periods of time
  • Ability to travel 10-30%
57

Senior Clinical Research Specialist Resume Examples & Samples

  • 4+ years experience directly supporting clinical research. Master’s degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience
  • Experience working directly with physicians
  • Experience with cardiovascular medical device and/or pharmaceutical trials
  • Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations
58

Clinical Research Specialist Resume Examples & Samples

  • University Masters or Bachelors degree in relevant technical, clinical or biomedical sciences. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience
  • 2-4 years experience directly supporting clinical research or similar experience in a medical/scientific area
  • Good problem-solving skills
  • Global perspective
  • Relationship building (able to work effectively on cross-functional & international teams)
  • Effective communication (advanced written and oral communications skills)
  • Courage
  • Planning
  • Results and quality oriented
59

Associate Clinical Research Specialist Resume Examples & Samples

  • Assist with the preparation and revision of study materials and/or training
  • Support the preparation of reports, regulatory submissions, publications and presentations
  • May arrange conference calls, staff meetings, and training events
  • Assist in the preparation and review of data
  • Oversee follow-up and resolution of sites issues
  • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks
  • Ensure appropriate filing of site documentation per SOPs
  • Contribute to process improvement initiatives and participate in training to enhance knowledge
60

Principal Clinical Research Specialist Resume Examples & Samples

  • 7+ years experience directly supporting clinical research
  • Computer skills (MS Office products, word processing, spreadsheets, etc.)
  • Demonstrate a high level of strategic thinking
  • Navigates complex challenges and solves problems
  • Takes ownership and self-motivated
  • Excellent project management skills
  • Excellent written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Subject matter and therapy expert for trial or program
  • Innovative - not afraid to think “outside the box”
  • Enjoy coaching/mentoring junior team members
  • Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
61

Clinical Research Specialist Resume Examples & Samples

  • Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies
  • Assist in preparation of sections of the Investigational Plan for assigned clinical studies
  • Assist in preparation of study materials and/or training Interface with, and assure training of investigators, site staff, and Medtronic clinical staff
  • Conduct site initiation (e.g. start-up document preparation, distribution, receipt, and review). Set-up and maintain accurate study status and implant logs
  • Conduct site monitoring
  • Assist in preparation of study budget and project plans
  • May arrange conference calls, staff meetings and training events
  • Assist in compilation and review of adverse event information
  • Assist in follow-up and resolution of site issues noted by field staff
  • You may be graduate level looking to start your career or
  • You may have 2 – 3 years’ experience directly supporting clinical research looking for a CRA role or
  • You may have 3 years + relevant experience and are looking for the next step in your career in a Senior CRA role
  • Ability to manage multiple tasks, good prioritization and organizational skills
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Associate Clinical Research Specialist Resume Examples & Samples

  • Participates in overall study document development
  • Assists in preparation of study and/or department materials and training
  • Sets up and maintains accurate clinical study files
  • Tracks and maintains study documentation
  • Conducts quality check on study documents
  • Conducts periodic reviews of study files to assure compliance with Standard Operating Procedures and study specific requirements; actively drives completion of action items
  • Conducts periodic audits of clinical trial management system to ensure accuracy/consistency of use
  • May assist sites with information to answer IRB questions
  • May assist sites with answers to protocol questions, regulations, and screening of patients
  • May perform data review, generating queries and reports; generating data discrepancies and reviewing completed discrepancy documents
  • Assists with study closure activities
  • Contributes to ongoing department improvement/standardization initiatives
  • Assists clinical management with other duties as requested
  • Familiar with clinical systems for trial management
  • Knowledge of GCPs and regulatory and compliance guidelines for clinical trials
  • Knowledge of medical device research
  • Knowledge of cardiovascular anatomy/disease
  • Computer experience with knowledge of word processing and applications such as Word, Excel and PowerPoint
  • Demonstrated independent working skills
  • Ability to work well in a dynamic, fast paced work environment
  • Accuracy and attention to detail essential
  • Ability to travel as needed
  • Ability to travel up 10-20%
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Senior Clinical Research Specialist Resume Examples & Samples

  • Minimum 4 years’ experience directly supporting clinical research
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is
  • Ability to travel up to 10%
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Senior Clinical Research Specialist Resume Examples & Samples

  • MD or PhD in Medicine, Anesthesia, Intensive Care Nursing or Microbiology, preferably with experience as study investigator
  • Ability to determine and evaluate economic value in clinical applications for enabling implementation of change
  • Excellent scientific communication, medical writing, organizational and negotiation skills
  • Ability to work collaboratively with a broad range of global stakeholders
  • Strong knowledge on clinical trials designs, GCP and regulatory requirements
  • Scientific publication and presentation experience
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Clinical Research Specialist Resume Examples & Samples

  • Identifies patients for clinical studies
  • Collects data as required by the study protocol. Functions may include but not limited to: vital signs, ECGs, ABPM, phlebotomy, including IVs
  • Process and ship lab specimens as required by the protocol
  • Prepares documents for submission to the INTEGRIS Health Review Board, the INTEGRIS legal department and to the sponsor for review
  • Collaborates with appropriate staff in the selection and feasibility of clinical studies
  • Provides education for the staff, patients and their families regarding research protocols, study medications and clinical procedures
  • May be required to write admitting orders and orders for the implementation of research protocols
  • Adjusts medications according to the study protocol in collaboration with the physician
  • Administer drugs according to protocol and maintains drug accountability in collaboration with the patient and sponsor
  • Inventories study drug and maintains drug accountability logs
  • Maintains research records including: source documents, case report forms, and system EMR
  • Prepares for and participates in sponsor monitoring visits, study initiation and closeout visits
  • Responsible for tracking and maintaining the quality and integrity of research trials
  • National travel for research studies as needed for Study Coordinators
  • Current professional Oklahoma license to include Registered Nurse (RN), Physical Therapist (PT), Respiratory Therapist or related field
  • 3 years clinical experience
  • Bachelors degree in related field may substitute for current professional license
  • Professional license is not required but preferred
  • Previous research experience required NZTI Only
  • Must be able to communicate effectively in English
  • Some travel maybe required
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Clinical Research Specialist Resume Examples & Samples

  • Ethical and participant safety considerations. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority
  • Data management and informatics. Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Assist in investigating incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow SOPs for data quality assurance. Use required processes, policies, and systems to ensure data integrity, provenance, and security
  • Communication and team science. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to othersas appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively
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Clinical Research Specialist Resume Examples & Samples

  • Bachelor’s degree in nursing or healthcare related field preferred
  • Three to five years’ nursing/clinical experience. Prior experience with management of research studies and statistical analysis
  • Knowledgeable of relevant regulatory guidelines
  • Excellent communication, analytical and interpersonal skills
  • Ability to work with health care professionals at all levels
  • Proficient computer and skills. Demonstrates commitment to the Partners-in-Caring process by integrating our culture in all internal and external customer interactions; delivers on our brand promise of “we advance health” through innovation, accountability, empowerment, collaboration, compassion and results while ensuring one Memorial Hermann
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Clinical Research Specialist Resume Examples & Samples

  • This is a REGULAR, PART-TIME (20 hours a week) position**
  • Recruit and screen subjects for research studies
  • Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research. Develop protocol manuals and data collection instruments
  • Perform clinical research activities including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals
  • Perform administrative duties such as providing training and guidance to students and other clinical staff. Participate in the design of research studies
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Clinical Research Specialist Resume Examples & Samples

  • Project Coordination. Review, analyze, and document project requirements. Monitor budgets and regulatory requirements. Engage with study participants in interviews. Keep electronic and paper file systems up to date and organized. Represent researchers in meetings and make decisions on project issues in coordination with project principals. Track and follow-up on things that were promised, but haven’t come through yet
  • Data Management. Support and assist study team to ensure accurate data collection and entry. Construct and maintain study databases. Assist project principals in identification and resolution of issues related to security and privacy regulations such as HIPAA. Liaison with data analysts and/or biostatisticians to record accurate information from physical or electronic medical records and oversee the secure maintenance of study data
  • Research Development and Support. Assist in writing and editing new research proposals. Conduct literature reviews. Prepare presentations, abstracts, lectures, posters, manuscripts, and educational materials
  • Communications. Prepare and present progress reports to clients, granting agencies, other stakeholders. Write business correspondence and procedure manuals. Assist in designing and finalizing newsletters and other marketing documents using Microsoft Publisher