Clinical Research Assistant Resume Samples

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CM
C Murray
Caitlyn
Murray
225 Leone Path
Phoenix
AZ
+1 (555) 568 4246
225 Leone Path
Phoenix
AZ
Phone
p +1 (555) 568 4246
Experience Experience
01/2015 present
Boston, MA
Senior Clinical Research Assistant
Boston, MA
Senior Clinical Research Assistant
01/2015 present
Boston, MA
Senior Clinical Research Assistant
01/2015 present
  • Update and maintain Clinical Development protocol number tracking log
  • Maintain Clinical Development SOP tracking log
  • Create or obtain, organize and file hard copies of clinical documents for clinical trials associated with Halozyme
  • Effectively organize and manage time
  • Create Study related template documents
  • Demonstrate attention to detail
  • Process Purchase Orders, Change Orders and/or invoices for study related CRO or Vendors
02/2012 11/2014
Los Angeles, CA
Clinical Research Assistant & Clinical Project Administrator
Los Angeles, CA
Clinical Research Assistant & Clinical Project Administrator
02/2012 11/2014
Los Angeles, CA
Clinical Research Assistant & Clinical Project Administrator
02/2012 11/2014
  • Assisting with the management of study supplies and organize shipments
  • Create, update, track, and maintain study-specific trial management files, tools, and systems
  • Assist with the management of study supplies and organize shipments
  • Provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP
  • Performing documents review, query generation and resolution against established data review guidelines, under direct supervision of Covance or client data management systems
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
  • Ensure compliance with SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
03/2005 10/2011
Chicago, IL
Clinical Research Assistant
Chicago, IL
Clinical Research Assistant
03/2005 10/2011
Chicago, IL
Clinical Research Assistant
03/2005 10/2011
  • Working in concert with the PI, and under the supervision of the project manager, helps with developing and implementing patient recruitment strategies
  • Assists in survey development, response tracking, data requests, prepares study materials, and ensures protocol adherence
  • Perform other duties as assigned by management
  • Perform other administrative duties as assigned by management
  • Provides guidance and training to the Clinical Research Assistant I
  • Works as part of the research team to provide support in coordinating the day to day activities in the Department of Research
  • Provides assistance on clinical research studies as per study guidelines and protocols
Education Education
Bachelor’s Degree in Computer Literacy
Bachelor’s Degree in Computer Literacy
Brigham Young University
Bachelor’s Degree in Computer Literacy
Skills Skills
  • Strong analytical skills and the ability to resolve technical or research problems and issues, and to interpret the acceptability of data results
  • Ability to communicate, assist and interact, in a professional and compassionate manner and ability to demonstrate respect for subjects and co-workers
  • Spanish proficiency highly desirable
  • Strong interpersonal skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Ability to work in fast-pace environment with significant attention to detail
  • A strong work ethic, excellent organizational skill, resourcefulness and desire to take initiative
  • Is able to function independently with no quality control audits beside one yearly audit
  • Good oral and written communication skills; careful attention to detail
  • Demonstration of strong organizational skills and ability to prioritize a variety of tasks
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15 Clinical Research Assistant resume templates

1

Lead Clinical Research Assistant Resume Examples & Samples

  • BS/BA, Masters' degree preferred in Life Science
  • Candidates should have 3-5 years relevant work experience
  • Have prior oncology experience, have strong experience with EDC systems experience, be proficient with MS Office Suite, and have highly effective interpersonal and organizational skills
  • Demonstrate the critical elements of GCPs and federal regulations as it relates to clinical monitoring, IRB and Investigator responsibilities
2

Clinical Research Assistant Director Resume Examples & Samples

  • Master’s in Business, Management, Nursing, Public Health or related field
  • Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience
  • Demonstrated experience leading and managing technical staff
  • Demonstrated experience leading large projects or programs
  • Demonstrated ability to work and communicate effectively with others
  • Mid-level management skills with experience developing strategies and leading the administrative and financial operations of a mid-sized organization to implement tactical programs in support of the strategies, preferably in a mid-sized research organization, innovation center, or an industry-based clinical research organization
  • Proficiency in Microsoft Office, salesforce, SAS and database applications
  • Familiar with Management techniques, including participatory decision making and levels of involvement
  • Excellent written, verbal, interpersonal, and presentation skills. Ability to communicate effectively with scientific, medical, professional, executive, administrative, and other personnel at all levels of an organization. Ability to build relationships and enable effective communications
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices
  • Experience both with Stanford and industry practices. Previous entrepreneurship is a plus
  • Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies
3

Clinical Research Assistant Resume Examples & Samples

  • Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes. Identifies and communicates important protocol and data management issues to appropriate individuals
  • Verifies that patients have completed appropriate registration materials and maintains related records and information
  • Instructs volunteers on protocol requirements and explains procedures and consent forms. Ensures related documentation is properly completed
  • Ensures protocol compliance with intense monitoring of specific study requirements and schedules protocol related treatment and tests. Performs specific clinical duties as required per the research study
  • Assists in ordering and maintaining research supplies as directed
  • Prepares and maintains a variety of documentation in assigned area of responsibility
  • May serve as a backup, collecting and delivering specimens for analysis using appropriate or specified equipment. Ensures proper labeling and obtains pertinent clinical and protocol information on request forms
4

Clinical Research Assistant Resume Examples & Samples

  • Performs data entry for research projects and maintains databases
  • Assists in the preparation of technical reports; summaries; and protocols
  • Maintains study related documents and supplies in the investigator's office; secures; organizes and
  • Documents as required following all federal/ state regulations
  • Creates; collects; disseminates; maintains appropriate files of study data; and assists with review
  • And completion of study manuals and SOPs
  • Extracts data from patient medical records; transcribes and resolves data queries in case report
  • Forms (hardcopy or electronic); prepares documents; under direction of project leaders; reports
  • Statistical analyses and descriptive data from patient's study books to be used in research reports
  • Maintains awareness and compliance of research regulatory issues
  • Communicates regularly with study team; under direction of project leaders; via email and
  • Conference calling as needed
5

Clinical Research Assistant Resume Examples & Samples

  • 1 Preparing Institutional Review Board (IRB) materials and communications
  • 2 Maintaining regulatory binders
  • 3 Recruiting and retaining study subjects
  • 4 Research billing compliance
  • 5 Performing procedures and collecting data
  • 6 Query resolution
  • 1 Performing phlebotomy and collecting blood samples
  • 2 Collecting urine samples
  • 3 Handling, processing and shipping laboratory samples
  • 4 Performing and recording study subject vital signs, height, and weight 5 Distributing and collecting subject diaries and questionnaires
  • 6 Performing other study specific procedures or tests as deemed appropriate
6

Clinical Research Assistant Resume Examples & Samples

  • Preparing Institutional Review Board (IRB) materials and communications
  • Maintaining regulatory binders
  • Recruiting and retaining study subjects
  • Research billing compliance
  • Performing procedures and collecting data
  • Query resolution
  • Performing phlebotomy and collecting blood samples
  • Collecting urine samples
  • Handling, processing and shipping laboratory samples
  • Performing and recording study subject vital signs, height, and weight
  • Distributing and collecting subject diaries and questionnaires
  • Performing other study specific procedures or tests as deemed appropriate
  • 3 Years of Experience
7

Clinical Research Assistant Resume Examples & Samples

  • Practical and dexterous
  • Can work effectively under pressure
  • Use of initiative, ability to meet deadlines and work prioritisation
8

Clinical Research Assistant Resume Examples & Samples

  • Bachelor's degree required, preferably in a health related field or an equivalent combination of related education and relevant experience
  • Have the ability to use the internet and other computer programs, i.e., database applications, etc
  • Exceptional organizational skills and attention to detail required
  • Must be able to multitask and to work independently
  • Must be able to interact effectively with a wide range of individuals at all levels in the organization
  • Must be a strong team player
9

Clinical Research Assistant Resume Examples & Samples

  • Experience coordinating, planning or working in a high volume multi-task setting. Knowledge of Oracle software, Medidata Rave, EPIC and ONCORE. Knowledge of federal regulations for HIPAA and IRB
  • Proven experience working in a Clinical Trials setting and ability to make high-level decisions relating to study
  • Working knowledge of medical oncology terminology
  • Proven ability to multi-task, maintain confidentiality and manage a broad variety of duties and shifting priorities in a changing environment and to be organized and meticulous with details
  • Impeccable interpersonal skills and the ability to work as a team as well as independently while self- motivating. Professional appearance and manner as well as an excellent attendance record. Experience working with study sponsor personnel a plus
  • Advanced computer skills with Excel, Word and competence with electronic medical databases. Ability to sit for prolonged periods of time
10

Senior Clinical Research Assistant Resume Examples & Samples

  • Assist clinical staff in their absence to field and respond to communications (e.g., phone calls, faxes, letters, or emails) as needed
  • Contact and correspond with study investigative sites, as needed
  • General administrative functions as needed (mailing documents, photocopying, etc.)
  • High school level diploma required; BA/BS in one of the life sciences strongly preferred
  • The Senior Clinical Research Assistant 2 will be an individual with a minimum 2 years of experience working the clinical or medical affairs department of a CRO, biotech, or pharmaceutical company
  • Clinical background or experience preferred
  • Knowledge of Good Clinical Practice preferred
  • Prior experience with a small entrepreneurial biotech or pharmaceutical environment is a definite asset
11

Clinical Research Assistant Resume Examples & Samples

  • Required: Minimum of 1 year professional experience in a research or patient care environment
  • Preferred: 1-2 years of experience in the conduct of research, interviewing research participants, or working with patients with complex mental health disorders
  • Working knowledge of mental illness, addiction, and research methodology
  • Experience using computer programs such as Endnotes and Microsoft Office products
  • Organized, detail-oriented, self-directed, and dependable
  • Strong time management skills and ability to prioritize workload
  • Excellent Microsoft Office computer skills
  • Able to learn VA regulations and procedures regarding research
  • Effective interpersonal skills, excellent verbal communication and written skills
  • Ability to work in different clinic locations as needed
12

Clinical Research Assistant Resume Examples & Samples

  • Supporting submissions to Medical Products Agency (MPA) and Ethics Committee (including supporting of local ICF)
  • Financial tasks and in-house trial management (including eTMF and payments)
  • Provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP
  • Act as contact for project team and study sites
  • Assist with the management of study supplies and organize shipments
  • Ensure compliance with S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
  • Diploma - Highier Education
  • Ability to set priorities and handle multiple tasks simultaneously
13

Clinical Research Assistant Resume Examples & Samples

  • Provide clerical support for clinical projects according to Client Standard Operating Procedures (SOPs)
  • Maintain administrative systems (tracking and other) for clinical projects according to Client SOPs
  • Assume a coordinating role for the project team concerning administrative matters
  • Provide telephone coverage and related support duties
  • Set up and maintain clinical investigator files and documentation
  • Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
  • Data entry and maintenance of selected study tracking databases
  • Prepare monitoring visit documentation for Clinical Research Assistants and above, as requested by supervisor
  • Prepare study-related documents and other materials for delivery to archives, at appropriate intervals
  • Perform other administrative duties as assigned by management
14

Clinical Research Assistant Resume Examples & Samples

  • Assisting with generation and reconciliation of queries to investigative sites/clients to resolve problem data
  • Assisting with the management of study supplies and organize shipments
  • Assisting the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)
  • Expeirence in clinical research area
  • Work efficiently and effectively in a matrix environment
  • University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
  • Fluency in local and good knowledge of English language
15

Clinical Research Assistant Resume Examples & Samples

  • Experience with Power Point and Excel required
  • Exposure to clinical and/or medical/psychological research preferred
  • Experience with research and grants administration preferred
  • Experience working in an academic healthcare center preferred
  • Experience with database management and analysis preferred
  • Administrative experience preferred
  • Strong critical thinking skills and ability to independently resolve problems
  • Working knowledge of data management software and procedures
  • Working knowledge of clinical research protocols and Good Clinical Practice
  • Ability to work independently under minimal supervision
16

Clinical Research Assistant Resume Examples & Samples

  • A Bachelor’s degree preferred in science or health-care field, or equivalent. Clinical research experience or research methods background preferred
  • Experience with programming (e.g., MATLAB) desirable
  • Demonstrated proficiency using computer-based tools (MS Office: Word, Excel, Powerpoint, Outlook etc.)
17

Clinical Research Assistant & Clinical Project Administrator Resume Examples & Samples

  • Create, update, track, and maintain study-specific trial management files, tools, and systems
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
  • Degree educated
18

Clinical Research Assistant & Clinical Project Administrator Resume Examples & Samples

  • Performing documents review, query generation and resolution against established data review guidelines, under direct supervision of Covance or client data management systems
  • Creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems
  • Basic understanding of biology and biological processes
  • Exhibit general computer literacy
  • Works efficiently and effectively in a matrix environment
19

Clinical Research Assistant Resume Examples & Samples

  • Prepare submission for approval to Ethics Committees and Regulatory Agencies, handle investigator contracts
  • Provide clerical support to project team (e.g., assemble study documents, shipment of study files, word processing, proofreading and editing correspondence, etc.)
  • Prepare monitoring visit documentation for Clinical Research Associates
  • Data entry and maintenance of selected study tracking data
  • Assist with coordinating vendors
  • Organize/prepare for client meetings/teleconferences
  • Assist/prepare for client or internal audits
  • Previous experience working with Essential Documents and / or Budgets in Clinical Trials, of investigator documents and the applicable regulations as Clinical Project Administrator at either a CRO, sponsor or hospital environments
  • Good organizational and time management skills. Ability to set priorities and handle multiple tasks simultaneously
  • Computer literacy (word processing and spreadsheet software)
  • Good typing skills
  • Good spelling and proofreading skills
  • Aptitude for handling and reviewing numerical data
  • Ability to operate standard office equipment (e.g., fax, copier)
  • Fluent German & English, both written and verbal
20

Clinical Research Assistant Resume Examples & Samples

  • Works as part of the research team to provide support in coordinating the day to day activities in the Department of Research
  • Collect, record, evaluate, update, and store/transport pertinent data and samples in relation to study protocol
  • Track study enrollment and completion of study milestones
  • Stock, inventory, store, and order samples/supplies as needed to maintain appropriate operations
  • Screen and recruit subject for clinical studies including obtaining vital signs
  • Assist with submissions to the Institutional Review Board (IRB) i.e., new studies, annual renewals, IND safety letters and following documentation for return acknowledgement from IRB
  • Assist in preparation of research participant visits
  • Enter data from patient charts into electronic data capture systems
  • Comply with established policies, health and safety regulations and requirements, procedures, and department objectives
  • Maintain patient and study subject confidentiality
  • Bachelor's degree in a scientific or health care field, or related experience
  • Excellent organizational and interpersonal skills required
  • Flexibility and ability to manage numerous tasks concurrently and ability to act cooperatively with many individuals
  • Demonstrate ability to pay attention to detail and to perform with accuracy
  • Positive, energetic, team�oriented professional outlook
  • Highly proficient with MS Office (Word, Excel, Power Point)
21

Clinical Research Assistant Resume Examples & Samples

  • Bachelor’s Degree, preferably in a life science or health science discipline
  • Minimum 1-2 years of related experience
  • Computer software skills (MS Word, Excel, Outlook, PowerPoint, and Access experience)
  • Strong attention to detail, self-motivation, and good organizational skills
  • Ability to multi-task and ability to work both as part of a team and independently
  • Minimum 1 year of industry experience, including clinical research and clinical operations experience
  • Bachelor’s degree, preferably in a life science or health science discipline
  • Experience working in healthcare industry or research function
22

Clinical Research Assistant Resume Examples & Samples

  • Bachelor’s degree, preferably in a clinical or scientific related discipline
  • One to two years of work experience in a research setting
  • Competence in research methodologies
  • Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results
  • Excellent interpersonal skills are required for working with the study participants and working as a team member
  • Knowledge of statistical software (SPSS, R, or Stata) preferred
  • Strong working knowledge of Microsoft Office
  • Excellent organization skills and ability to prioritize a variety of tasks
  • Ability to demonstrate professionalism and respect for participants and individual needs
23

Clinical Research Assistant Resume Examples & Samples

  • Assists in maintaining data, subject files, regulatory documents and study databases, under the supervision of the PI and other study staff
  • Under the supervision of other study staff, scans and files paper research records to assist with the digitization process for past records
  • Assists in screening research subjects for suitability in close collaboration with the PI and other study staff
  • Acts as resource for patients and families
  • Administers study questionnaires, collects data and performs data entry as needed for study protocols
  • Assists in coordinating (with other clinical and research personnel) study visits that require EKG, phlebotomy, vital signs, lumbar punctures, intrathecal injections of investigational medication, DEXA scans, physical therapy assessments
  • Assists in filing documentation with IRB, including amendments and annual reviews
  • Assists with writing protocols and manuscripts
  • Works with PI to complete study reports
  • Assists with billing of research study-related costs
  • Assists in coordinating research activities alongside clinical care where needed, which may include both inpatient and outpatient settings
  • High degree of computer literacy required
24

Clinical Research Assistant Resume Examples & Samples

  • Chart review and data abstraction
  • Study and protocol coordination
  • Survey/questionnaire administration
  • Data collection/management
  • Tissue and blood sample collection/management
  • IRB preparation and submission
  • Identifying and recruiting study subjects
  • Monitoring follow ups
  • Ability to work well within a multi-disciplinary team
  • Facility with Microsoft Word and Excel
  • Ability to perform focused literature searches
  • A strong work ethic, excellent organizational skill, resourcefulness and desire to take initiative
25

Clinical Research Assistant Resume Examples & Samples

  • Track the collected tissue specimens and molecular findings
  • Maintain a comprehensive database of specimens and clinical outcomes
  • Interact with patients related to the project
  • Interact with pathology lab team members related to the project
  • Interact with translational breast team and provide regular updates on the project
  • Excellent organization and communication skills
  • Familiarly with Microsoft excel and other databases
  • Ability to interact and communicate with patients and team members
  • Experience of shadowing physicians and/or interacting with patients in clinic
26

Clinical Research Assistant Resume Examples & Samples

  • Conducts literature search and article retrievals
  • Enrolls subjects into the clinical studies
  • Conducts in-person or telephone interviews of subject
  • Develop and complete subject surveys
  • Data abstraction, maintenance and storage, and analysis of subject information
  • Prepare reports and manuscripts for presentations
  • Assists with grants preparation
  • Develops and oversees IRB applications, including protocols, informed consent documents, trial registration, and HIPAA forms as well as modifications and renewals
  • Assist with delivery of care coordination intervention
27

Clinical Research Assistant Resume Examples & Samples

  • Theoretical knowledge in psychology or public health typically acquired at a collegiate level or comparable years of experience
  • Demonstrated experience in recruiting research subjects for clinical research program and understanding of issues related to eating disorders
  • Proven effective interpersonal skills and oral/written communications skills, including the ability to administer face-to-face and telephone interviews and keep accurate and detailed records
  • Experience in a research setting involving human subjects and knowledge of HRPP compliance issues
  • Strong basic computer skills such as word processing and data entry, as well as extensive experience with Microsoft Word and Microsoft Excel
  • Excellent interpersonal communication skills to communicate clearly, effectively, tactfully, and patiently in-person, on the phone and in writing to a diverse population; including faculty, staff, vendors, drug reps, and patients
  • Demonstrated ability to answer, screen, and direct calls/visitors and take complete, accurate messages
  • Excellent customer service skills with kindness and professionalism
  • Demonstrated experience in coordinating clinical assessments and in-person interviews with subjects, researchers and other multiple programs for the research program
  • Proficiency to read, write, speak and translate English to Spanish
28

Clinical Research Assistant Resume Examples & Samples

  • Under supervision of the PI, coordinates the implementation, both internally and externally, of sponsored clinical research studies
  • Collects and organizes patient data, may initiates and maintain contact with study participants. Once trained, maybe responsible for assisting with screening applicants over the phone, ensuring they meet appropriate criteria
  • Once trained, will perform bilateral arm volume measurements on patients
  • Collects computerized questionnaire data from research participants during lymphedema assessments
  • Working in concert with the PI, and under the supervision of the project manager, helps with developing and implementing patient recruitment strategies
  • Develops, organizes, and/or maintains study databases. Responsible for data entry and quality control of data. May conduct basic data processing and statistical analysis of quantitative and/or brain imaging data after training from project manager and other staff
  • In conjunction with the PI, develops, and under the direction of project manager, assists with writing, and implementation of new research protocols including design, data collection systems and institutional review board approval (IRB). May contribute to changes to research protocols
  • Assists PI with preparation of slide presentations, poster boards, and research articles
  • Performs all other duties as assigned
  • Ability to work independently under the supervision of the study PI and/ or program manager
  • Strong and proactive interpersonal skills are required for working with the study participants and working as a member of a highly integrated team
  • High degree of computer literacy, including UNIX, Mac OSX, Microsoft Office (Word, Excel, Powerpoint), and Windows OS; SPSS and MATLAB skills preferred
29

Clinical Research Assistant Resume Examples & Samples

  • Manage and analyze data using SPSS and Excel
  • Summarize project results in PowerPoint and written reports
  • Perform literature reviews using scientific databases
  • Prepare materials for submission to granting agencies and foundations
  • Prepare Institutional Review Board (IRB) applications
  • Provide ready access to all data for the executive director and scientific advisor
  • Attend area seminars and other meetings as necessary
  • Prepare other articles, reports, and presentations
  • Computer skills: Ability to analyze data using Excel and statistical software packages (e.g. Stata, SPSS or SAS)
  • Organizational skills: Ability to independently manage projects and meet deadlines
  • High level of maturity and professionalism
30

Clinical Research Assistant Resume Examples & Samples

  • Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
  • Assist CRAs and project team members with one site tasks (e.g. review of Case Report Forms and Study File Notebook, drug accountability) other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings)
  • Minimum 0,5 year previous Experience in clinical trials
  • Diploma – Secondary Education or equivalent
  • Fluency in Bulgarian and English language
31

Clinical Research Assistant Resume Examples & Samples

  • College education with courses in public health, community program development, psychology/sociology, and research, or equivalent experience in a related field
  • Advanced level proficiency in Microsoft Access, Microsoft Word, Internet, and e-mail
  • Valid driver's license and reliable transportation
  • 1 year of research or data entry/registry experience
  • Experience in tumor registries, ABMT registries, and cancer clinical research
  • Previous lab experience strongly preferred
  • Must be comfortable handling biospecimens including blood, urine and tissue samples
32

Clinical Research Assistant Resume Examples & Samples

  • Must possess strong interpersonal skills and ability to work with individuals across all levels of organization
  • Must possess strong multi-tasking skills
  • Must possess proficient planning, typing and organizational skills
33

Clinical Research Assistant Resume Examples & Samples

  • Collect and record study data and input all information into the database
  • Obtain informed consent under minimal supervision of the PI and educate participants regarding study requirements
  • Distribute supplies for urine collection to the subjects enrolled in the trial
  • Collect, process and store urines samples prior to laboratory based isolation of exosomes and microRNAs
  • Assist in the activities related to clinical research studies including but not limited to; answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency
  • Maintain source documents and subject files in accordance with hospital procedures
  • Ensure accurate and complete compilation of subject data through chart reviews
  • Assist in the preparation of manuscripts, presentations, site visit and meeting binder and other duties as assigned
34

Clinical Research Assistant Resume Examples & Samples

  • Adheres to approved recruitment & enrollment strategies
  • Maintains regulatory documents per the established protocol or sponsor requirements
  • Creates/reviews source documents and sets up study files
  • Assist in the preparation of reports and professional research papers
35

Clinical Research Assistant Resume Examples & Samples

  • Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires
  • Performs other related duties
  • Associates Degree in Science or closely related field preferred or HS/GED plus two years of related experience
  • 0-1 year in research environment preferred
  • Exceptional attention to detail and accuracy
36

Clinical Research Assistant, Cancer Institute Resume Examples & Samples

  • Collects and records study data. Inputs all information into database
  • Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews
  • Secures, delivers and ships clinical specimens as required by the protocol
  • Assists in the preparation for monitoring visits
37

Clinical Research Assistant Resume Examples & Samples

  • Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
  • Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)
  • Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
  • Provide input in writing Monitoring Conventions as assigned
38

Clinical Research Assistant Resume Examples & Samples

  • Train and mentor Clinical Project Administrators
  • Provide clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
  • Minimum of four (4) years administrative experience in a corporate environment or, minimum of four (4) years Clinical Project Administrator experience
  • Demonstrated aptitude for training
39

Clinical Research Assistant Resume Examples & Samples

  • Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols. May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol
  • Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator
  • Discusses informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests
  • Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects. Reviews protocol requirements with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to learn how to independently resolve problems with protocol
  • Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols. Enters data into computerized system
  • Assists investigator with correspondence with IRB. (essential)
  • Working knowledge of computerized data (word processing, spreadsheets, and database)
  • Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access
  • Previous clinical research project experience
40

Clinical Research Assistant Resume Examples & Samples

  • Bachelor’s degree in the area of biological sciences
  • Undergraduate immunology course completion
  • Knowledge of the research process and/or experience in human subject’s research
  • Preferred experience with social media outreach and web design
41

Clinical Research Assistant Resume Examples & Samples

  • Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Recruits and enrolls patients onto clinical trials according to study protocols
  • Checks all eligibility and ineligibility criteria with patients' medical record. Verifies information with clinical research nurse and/or principal investigator
  • Discusses informed consent with patients. Documents any adverse events that occur. Interacts with patients prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests
  • Monitors strict adherence to protocols by physicians, nurses and patients. Reviews protocol requirements with physicians, nurses and fellows. Identifies problems with protocol compliance and works with research nurse and principal investigator to make corrections
  • Extracts data on protocol patients from hospital records, outpatient charts and private physician office records in order to complete case report form required by specific protocols
  • Bachelor's degree required. Master's degree preferred
  • Bachelors degree and one year experience in a medical setting and/or clinical research or a Master's Degree
  • Working knowledge of computerized data required including word processing, spreadsheets and databases
42

Clinical Research Assistant Resume Examples & Samples

  • Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting and following up on Serious Adverse Events
  • Develops source documents, assists the PI in developing consent and assent documents, assists in protocol preparation, assists with IRB submissions for assigned studies, maintains regulatory documents during the course of the study, and develops and maintains documents as required by sponsoring agencies
  • Collects data and monitors data integrity, including completeness, accuracy and quality; develops and maintains study databases
  • Attends Investigator Meetings, as assigned. Helps develop and deliver in-services for staff for study purposes. Collaborates effectively with research team members across study sites
  • Develops and maintains data-gathering materials and procedures that may include electronic data capture technology
  • Identifies potentially eligible participants, recruits patients, gathers and documents informed consent and assent, and schedules data collection sessions, all in accordance with study protocols
  • Assists in quantitative and qualitative data analysis
  • Assists in manuscript/abstract preparation
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Clinical Research Assistant Resume Examples & Samples

  • Support the CRA II with IRB and regulatory work for hematology/oncology research studies submitted under the Nemours NCORP structure
  • Responsible for assisting in the coordination and preparation of multi-sited IRB submissions and maintaining regulatory documents until study closeout
  • Draft study-specific documents, prepare packages for submission to regulatory boards, and maintain study files
  • Maintain close communication and good customer relationships with sponsor representatives
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Clinical Research Assistant Resume Examples & Samples

  • Bachelor’s degree required; Life Sciences, Statistics, Mathematics majors, and MPH applicants are encouraged to apply
  • 2+ years experience in clinical research
  • Excellent oral and written communication skills (publications are a plus)
  • Computer literacy: Microsoft Word, Excel, PowerPoint, data management
  • Detail oriented, organized, and able to multitask
  • Experience with statistical analysis is a plus (MPH candidates encouraged to apply)
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Clinical Research Assistant Resume Examples & Samples

  • Undertake coordinating tasks of clinical research studies
  • Assist investigator in successful recruitment and retention of
  • Required a minimum of 3-5 years of clinical experience or an equivalent combination of education and experience
  • Proficiency in phlebotomy and intravenous access
  • Highly proficient in Microsoft Word and Excel
  • LPN with NYS licensure
  • RN with a current NYS licensure
  • Familiar with clinical research procedures and
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Clinical Research Assistant Resume Examples & Samples

  • For new site/CRO, perform pre-qualification visit and write report. Identify gaps and follow up on action plans until resolved
  • Conduct site monitoring of cosmetic studies per the monitoring plan, including source document verification, reconciliation of investigational product, checking of the informed consent documents, verification of inclusion/exclusion criteria, verification of the appropriate delegations and responsibilities of the site staff and facilities, and reconciliation of Site Master File (SMF)
  • Prepare site corrective action plans when necessary which may include retraining of site staff (protocol, GCP, etc)
  • Responsible for initiation visits, monitoring and close-out visit, either remotely or in person, ensuring training of the PI and the site staff to the Protocol and also for documenting appropriately each visit
  • Verify that the study is conducted according to the protocol and any amendments, reporting all protocol deviations to Study Manager
  • Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines, escalated, reconciled and documented appropriately, including queries with data management
  • Assist in all audits and inspections
  • Support set-up and maintenance of TMFs, ensuring that all TMFs are ready for audit at any time
  • Ensure that the site maintains updated documents in the SMF and that the SMF is ready for audit at any time
  • Act as study manager for cosmetic studies, ensure that all related study documents are prepared reviewed and approved, managing study timelines including key milestones
  • Provides appropriate oversight of sites, CROs and/or suppliers
  • Serve as the primary point of contact with Investigators and J&J Study Team
  • Manages progress of studies and ensures timely review and approval of monitoring visit reports
  • Identifies and escalates study-related issues and deviations to study team and senior management
  • Manage study timelines including key milestones
  • Ensures review and approval of CSRs
  • BS in Pharmacy, Bio-Engineering, Chemistry Engineering, Medicine or related health care field
  • Required minimum of 1 year site monitoring or related clinical research experience, preferably on cosmetic clinical studies
  • Knowledge of ICH GCP required
  • Mandatory advanced English
  • Availability for travels.0855170510
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Clinical Research Assistant Resume Examples & Samples

  • Recruits and evaluates potential study patients. Per protocol instruction, conducts telephone interviews or schedules patient for study visit and screening. May be required to perform clinical tests such as phlebotomy, EKG’s, etc
  • Answers any phone all and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff
  • Monitors and sets up any needed equipment
  • High degree of computer literacy, including SPSS
  • Analytical skills and ability to resolve technical problems
  • Highly organized and efficient
  • Minimum 1-2 years related experience
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Clinical Research Assistant Resume Examples & Samples

  • Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate interventions for program participants. Obtain data regarding participants in accordance with study protocols and in collaboration with other study team members
  • Assure compliance with all relevant IRB and other regulatory agency requirements. Assure personal and team compliance with VA and MCW research training requirements
  • Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols
  • Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports
  • Work with Principal Investigator(s) and analysis staff to develop, implement, and maintain comprehensive databases and files related to the program
  • Maintain program timeline including tracking deadlines for program components
  • Perform phlebotomy, separate serum from cells and store in appropriate storage location. All of these are performed following a standard protocol using safe technique
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Clinical Research Assistant Resume Examples & Samples

  • Accurately enter research data onto case report forms or specified programs (OnCore) and other databases as appropriate under the direction of the research nurse or study coordinator
  • Under the direct guidance, assist with coordination of basic study activities
  • Prepare specimen tubes prior to lab draw and transport specimens from lab to process and send out
  • Assist with processing of lab specimens in preparation for send out or storage
  • Prepare shipping labels and document labels for both data and specimens
  • Coordinate patient visits to clinic. Organize study participant charts and files, and distribute to appropriate location
  • Collect required data from study coordinators and research nurses, and enter onto clinical research forms and into computerized database
  • Order and maintain log of stipend checks and/or gift certificates to be distributed to study participants
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Clinical Research Assistant Resume Examples & Samples

  • Under the direction of the program manager and principal investigator, conduct research activities at schools in Southeastern Wisconsin. Recruit, enroll, and administer study assessments with study participants per the study protocol
  • Collect required data and enter onto clinical research forms and into computerized database
  • Provide general clerical support to nurses and investigators
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Clinical Research Assistant Resume Examples & Samples

  • Under direction of the study coordinator or principal investigator, conduct research activities to include visit study participant homes, community centers and other community settings to interview, administer surveys, recruit, and enroll and follow-up with study participants as directed
  • Coordinate research related projects such as mailings, participant contact information, patient visits and focus groups
  • Collect samples from patients as needed. Process and transport samples as directed
  • Collect required data from study coordinators and research nurses. Code and enter onto clinical research forms and into computerized database
  • Order and maintain log of stipend checks and/or gift certificates to be distributed to study participants. Verify accuracy of bills and stipends
  • Provide general clerical support to nurses and investigators. Compose letters to study participants
  • Provide writing and editorial assistance in the preparation of grants, manuscripts and other study related reports. Assist with the creation of brochures, flyers and educational materials. Conduct literature searches
  • Translate oral and written communication to and from English, if required
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Clinical Research Assistant Resume Examples & Samples

  • Organize study participant charts and files, and distribute to appropriate location
  • Provide general clerical support to study coordinator or principal investigator. Compose letters to study participants
  • Coordinate with community based organizations and coalitions
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Clinical Research Assistant Resume Examples & Samples

  • BA or BS Degree
  • Must have at least one year of directly related clinical research experience, and have demonstrated competence in research techniques and methodologies
  • Research experience working with data collected from questionnaires and patients preferred. Previous experience working with clinical research regulatory documents and the IRB preferred
  • High degree of computer literacy; knowledge of data management programs
  • Proficiency in statistical analysis of clinical research data
  • Excellent interpersonal skills are required for working with the study participants
  • Good oral and written communication skills; careful attention to detail
  • Ability to demonstrate professionalism and respect for subjects’ rights and individual needs
  • Must be able to consistently demonstrate McLean Values of integrity, compassion and respect, diversity and teamwork, excellence and innovation in their work activities and interactions
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Clinical Research Assistant Resume Examples & Samples

  • Experience working within a clinical practice for neurology/related experience is a plus
  • Proficiency in computer skills including Microsoft applications, Internet, and e-mail
  • Proficiency in using other office electronic equipment
  • Post high-school education and/or research experience
  • Experience in conducting interviews and administering surveys
  • Experience with clinical research trials as an assistant to a Clinical Trials Coordinator
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Clinical Research Assistant Resume Examples & Samples

  • Experience working in a medical setting interacting directly with patients, and/or clinical research setting
  • Recent (within 2 years) CITI training or comparable GCP training preferred
  • Current CPR preferred
  • Experience with EMR and electronic scheduling systems required
  • Excellent computer skills, ability to enter data quickly and accurately, and ability to learn new systems quickly
  • Ability to use Microsoft Excel to create spreadsheets and manage information required
  • Strong attention to detail and excellent organizational and time management skills required
  • Ability to communicate effectively, in a professional manner, verbally and in writing, required
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Clinical Research Assistant Resume Examples & Samples

  • Perform data collection by conducting research interviews. Recruit and screen subjects for research studies. Collect baseline and follow-up data from subjects including verification of eligibility; obtaining consent and enrollment
  • Coordinate study recruitment; monitor interviewers and procedures; establish and maintain database files and report on progress of programs, studies, and/or projects
  • Conduct manualized one-on-one treatment intervention sessions regarding smoking cessation with study participants
  • Perform administrative duties such as: providing training and guidance to interviewers, assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies, developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies, and participating in the design of research studies
  • May perform telephone interviews check validity and accuracy of data ensuring compliance with quality control requirements and clinical relevance
  • Possess knowledge of clinical recruitment and interviewing. Able to perform position in compliance with all requirements, regulations, and laws. 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. Skill in statistical interpretation and data analysis using statistical software as well as spreadsheet and database software applications. Ability to participate in the design of research studies and preparation of technical procedures and reports
  • Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to understand and utilize scientific/medical terminology and research theory in both verbal and written communications. 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. Ability to maintain confidentiality of subjects and information obtained
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Clinical Research Assistant Resume Examples & Samples

  • Maintains current and accurate protocol documentation and is aware of the timeliness of regulatory documents
  • Ensures that patients are appropriately scheduled, registered; maintains documentation of patient registration
  • Teaches scripted orientation program to the cancer center patient and their caregivers
  • Helps to train and mentor new clinical research staff members
  • Performs specific clinical duties as required per the research protocol
  • Collects and delivers specimens for analysis, using appropriate or specified equipment for collecting and handling specimens; ensures proper labeling and obtains pertinent clinical and protocol information on request forms; develops and maintains knowledge of various aspects of processing specimens, paying particular attention to safety practices
  • Identifies and communicates important protocol and data management issues or problem areas to supervisor
  • Ensures work environment is organized and functions efficiently
  • Attends and participates in meetings as required
  • Provides staff relief as required to meet the needs of the department
  • Communication - Expresses ideas clearly and constructively (written and spoken, upward and downward, one-on-one and with groups)
  • Stewardship - Identifies efficiencies to reduce redundancy and/or elimination of tasks resulting in savings of cost, resources, and or/time
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Clinical Research Assistant Resume Examples & Samples

  • Collects patient data from initial patient contact through course of therapy, rehabilitation, and long –term care
  • Enters all pertinent data in computer system in a timely manner as outlined by department guidelines
  • Generates custom reports to review patient progress and to be used for research and marketing purposes
  • Maintains patient data files in an organized manner for easy retrieval and review
  • Reports data to company Clinical Research network and applicable local, state, and federal accrediting bodies and/or agencies
  • Assists with scheduling consultations, diagnostic tests or procedures, and future appointments for patients with physicians as requested
  • Prepares patient records for audits by regulatory, accrediting, and research organizations
  • May assist physicians and nurses with direct patient care including vital signs and assisting in procedures
  • Follow patient to collect biopsy specimens from various facilities where the procedures are scheduled
  • May assist with collecting and processing specimens for research purposes. May maintain supplies, drugs and storage facilities for clinical research as appropriate
  • Minimum one year medical office experience, oncology preferred
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Clinical Research Assistant Resume Examples & Samples

  • 1 year of relevant clinical research experience in a pharmaceutical or CRO industry position
  • Additional experience may be substituted for education requirements
  • Meets all the expectations of an –CRA Assistant I and has been in role >1 year
  • Typically 1 year of relevant clinical research experience in a pharmaceutical or CRO industry position
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Clinical Research Assistant Resume Examples & Samples

  • Providing assistance with study visits including scheduling, collecting and organizing data, data entry, maintaining data base, responding to edits and queries coordinating the schedules of multiple staff members and off-site facilities
  • Demonstration of strong organizational skills and ability to prioritize a variety of tasks
  • Ability to juggle multiple tasks, people, and schedules
  • Ability to communicate, assist and interact, in a professional and compassionate manner and ability to demonstrate respect for subjects and co-workers
  • Ability to start work at 7:00 AM and work some weekends as needed for study visits
  • Ability to maintain quality, safety, and infection control standards
  • Desire to interact with study volunteers and work as part of a dynamic team
  • Must complete required hospital, departmental, and study specific training
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Clinical Research Assistant Resume Examples & Samples

  • Minimum offour (4) years administrative experience in a corporate environment or minimum of four (4) years Clinical Project Administrator experience
  • Demonstrated aptitude for training
  • Good oral and written communication skills
  • Ability to set priorities and handle multiple tasks simultaneously
  • Good organizational and time management skills
  • Computer literacy (word processing and spreadsheet software)
  • Good typing skills
  • Good spelling and proofreading skills
  • Aptitude for handling and reviewing numerical data
  • Ability to operate standard office equipment (e.g., fax, copier)
  • Works efficiently and effectively in a matrix environment
  • Fluent in local office language and in English, both written and verbal
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Clinical Research Assistant Resume Examples & Samples

  • Two years’ post high school education including completion of college level curriculum in a healthcare related field
  • Experience in oncology, clinical research, academic research or similar area
  • Over one year computer database experience
  • Minimum of one year customer service experience
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Clinical Research Assistant Resume Examples & Samples

  • Provides organizational, administrative and clinical assistance for designated research study programs
  • Performs activities in accordance with established policies and procedures related to clinical research study protocols, including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires
  • Serves as a liaison between research study participants, Clinical Research Coordinators and Principal Investigator
  • Provides guidance and training to the Clinical Research Assistant I
  • Prepares for monitoring visits
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Clinical Research Assistant Resume Examples & Samples

  • Possess knowledge of position requirements. Able to perform position in compliance with all requirements, regulations, and laws. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications. Assumes personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Skill in continuously seeking to improve the efficiency and quality of research operations. Maintains productivity and uses knowledge strategies to increase knowledge base
  • Ability to effectively communicate both verbal and written thoughts, ideas, and facts. 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 relevant PC applications (Word, Power Point, SPSS and Excel) and ability to learn computerized interview and examination procedures
  • Ability to maintain confidentiality of subjects and information obtained
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Clinical Research Assistant Resume Examples & Samples

  • Performs medical record abstraction for acute and rehabilitation data
  • Interviews individuals, family, and friends for premorbid history information, either in person, by telephone or by mail questionnaire
  • Completes standardized functional assessments on individuals in the hospital and in the community
  • Collects and explains informed consents to individuals and their families
  • Understands privacy and confidentiality requirements of medical and research files
  • Maintains paper and electronic records of collected data
  • May assist in analysis of collected data
  • Prepares and presents factual and statistical data at local research meetings
  • May be assist in creating professional publications and national level presentations of findings
  • Uses a variety of databases and information applications to track completion of projects
  • Acts as a resource in the study area
  • Attends community and educational activities outside of regular working hours
  • Adheres to reporting and tracking requirements i.e.; Semi-monthly project meetings, monthly staff reports, annual reports to funding agencies
  • Basic word processing, database, spreadsheet and office equipment use. Ability to
  • Conduct a supervised interview
  • Provide information and resource referral services to clients
  • Mail out and collect questionnaires (mail merge)
  • Clearly document data that is collected
  • Complete data entry through database applications
  • Provide written summary reports of needs and satisfaction assessments
  • Prepare written materials in accordance with publication guidelines
  • Participate in after hours community and educational activities as necessary
  • Assist other Clinical Research Assistants and Associates in the activities described above. Clinical Research Assistant II Experience Note: The knowledge and abilities to perform the functions of this position would normally be acquired by the attainment of an Associate's Degree in health care or related field. Relevant work experience may be substituted for the educational requirement. The applicant must be certified to use the Disability Rating Scale (DRS) or the Functional Independence Measure (FIM). Knowledge of
  • Basic background medical knowledge in the area of physical and mental disabilities
  • Principles and procedures for obtaining informed consent and basic human subjects rights, including HIPAA research guidelines
  • Standardized outcome and assessment measures (Functional Independence Measure, Disability Rating Scale, Satisfaction With Life Scale, etc.). Ability to
  • Abstract information from medical records
  • Conduct interviews (in person, by phone, by mail)
  • Recruit participants for research studies
  • Explain study protocols to participants, family members, and treatment team
  • Establish and maintain rapport with participants
  • Explain, collect, and maintain informed consent and privacy regulations paperwork
  • Prepare detailed assessments of work progress, including monthly staff reports and annual reports required by funding agency
  • Participate in at least one national Data Collector meeting per five-year grant cycle
  • Prepare materials, with supervision, for inclusion in dissemination activities, including, but not limited to, background information, statistical presentation (graphs, tables), and preliminary interpretation of data
  • Propose new activities and/or research ideas for research area
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Clinical Research Assistant Resume Examples & Samples

  • High School Diploma or G.E.D
  • Completion of Medical Assistant course can be utilized in this position
  • A Bachelors degree can be utilized in this position
  • Two to three years of relevant experience
  • Requires a working knowledge of computer applications
  • A working knowledge of research methodology, medical terminology preferred
  • Must be able to draw blood-preferred
  • Must be comfortable interviewing patients to enroll in Research studies-preferred
  • Must be comfortable working in the ED-preferred
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Clinical Research Assistant Resume Examples & Samples

  • Collect clinical data from physicians and research nurses, and enter into computerized database. Some limited clinical data collection from chart review may also be performed, consistent with the individual’s experience
  • Assist with the creation of brochures, flyers and educational materials. Compile outreach packets and recruitment materials
  • Provide writing and editorial assistance in the preparation of grants, manuscripts and other study related reports. Conduct literature searches
  • Depending on the individual’s level of interest, experience may also be gained in basic data reporting to assist in preparation of analyses for publication and presentation
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Clinical Research Assistant Resume Examples & Samples

  • Order and maintain log of stipend checks and/or gift certificates to be distributed to study participants. Verify accuracy of stipends
  • Generate letters to be sent to study participants
  • Under the direction of the study coordinator or principal investigator, assist in enrolling patients in educational and social intervention research studies. Contact patients as required after initial contact to obtain additional information
  • Compile outreach packets, recruitment and specimen collection kits
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Clinical Research Assistant Resume Examples & Samples

  • May help to assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol
  • Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests
  • Ensures accurate records are maintained for each study participant
  • Oversees specimen transport from the nursing unit to the clinical research laboratory
  • Assists in writing research applications and regulatory documents necessary for clinical trial operations
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Clinical Research Assistant Resume Examples & Samples

  • Graduate of a Medical Assistant program OR
  • Graduate of an EMT/Paramedic program
  • General knowledge of endocrine and metabolic disease processes
  • Strong interpersonal skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public
  • 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
  • Experience in the clinical/translational research environment (Preferred)
  • Computer skills, particularly Microsoft Outlook, Word, Excel, Publisher, PowerPoint, Cerner, use of internet and other research tools (Preferred)
  • Knowledge of clinical/translational research and research regulatory environment (Preferred)
  • If MA - American Association of Medical Assistants (AAMA) Certification, or American Medical Technologist (AMT) Certification, or ARMA (American Registry of Medical Assistants), or NCCT (National Center for Competency Testing), or NHA (National Health Career Association), OR
  • Current active State of Florida EMT license, OR
  • Current active State of Florida Paramedic license
  • BLS certified
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Clinical Research Assistant Resume Examples & Samples

  • Conducts qualitative, psychological, and physiological assessments of Cantonese and Mandarin speaking parent and child participants. Conducts the selection, scheduling, and monitoring of research participants
  • Engages with local community organizations and groups, prepares with research presentations, recruitment materials, and community outreach
  • Serves as a liaison between data collection sites and research investigators to ensure clear communication and study progress
  • Supervises data management. Ensures data remains clean and coded appropriately. Maintains impeccable study records. Assists with finding and applying for research funding
  • Prior experience with administering assessment and laboratory research tasks with human subjects
  • Ability to travel between sites within the greater Boston area for outreach and data collection
  • Fluent (speaking, reading) in Cantonese or Mandarin Chinese
  • Experience with biological, psychophysiological, or health related data collection as well as a familiarity with IRB. Experience working in an academic research setting and community setting
  • Undergraduate or advanced degrees in psychology, child development, or health or social sciences
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Clinical Research Assistant Resume Examples & Samples

  • Assists in survey development, response tracking, data requests, prepares study materials, and ensures protocol adherence
  • Assists with scheduling research interviews, focus groups and email communications
  • Participates in development and submission of study related documents to the IRB for each assigned study(s)
  • Participates in data analysis, programming, data management, abstracts, data tables, and presentations
  • Assesses potential participant's (patients and clinicians) eligibility for study inclusion based on protocol(s)
  • May review and obtain informed consent with patients and serve as the point of contact
  • Experience with SAS, STATA, SPSS, or similar data analysis software
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Clinical Research Assistant Resume Examples & Samples

  • Maintain up-to-date records related to clinical trials, which include: FDA regulatory binder, source documents (i.e., case report forms), and electronic records supplied by sponsors and maintenance of IRB approvals
  • Maintain up-to-date appointment schedules for subjects in clinical trials
  • Assist investigators while they have appointments with clinical trial subjects performing vital signs and maintaining study supplies
  • Meet with clinical trial (outside) study monitors to resolve queries on regulatory and study records on a continual basis
  • Maintain weekly communication of results as requested by PI
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Clinical Research Assistant Resume Examples & Samples

  • Establish and maintain the tracking tools for assigned trials for production of study metrics and reporting
  • Create, assemble and coordinate shipping of study materials
  • Conduct review and tracking of invoices & study payments, facilitate payments with Accounts Payable
  • Receive clinical study documents, review for completion with study team members, accuracy & expiration, and maintain the TMF
  • Review TMF inventory for missing and expiring documents
  • Support maintenance of the Trial Master File (TMF) and assist in quality assurance, as appropriate
  • Review and assist in the collection of essential documents for completeness and compliance with SOPs, the protocol and appropriate regulations
  • Distribute clinical trial related materials to sites or clinical team members
  • May act as a central contact for designated project communications, correspondence and associated documentation
  • Participate in team meetings and assist in preparation of agendas, minutes, and tracking of action items
  • Assist in the creation of clinical trial materials, including but not limited to documents, presentations, and reports
  • Perform administrative tasks to support Clinical Affairs, as needed
  • Assist in the preparation of regulatory submissions, including IDEs, PMAs, 510Ks, and foreign filings
  • Education and Training - BA/BS degree in Life Sciences, medicine or other technical field or equivalent combination of training and experience is preferred
  • Essential Skills and Abilities -
  • General knowledge of applicable clinical research principles and concepts,
  • Strong computer literacy including proficiency in Microsoft Word, Excel and PowerPoint
  • Requires above average reading, verbal and written communications skills; proficiency in business English and grammar; good arithmetic skills and attention to detail to maintain records and process reports
  • Ability to work in fast-pace environment with significant attention to detail
  • Highly effective communication and interpersonal skills
  • Physical Requirements
  • Majority of job is desk based, with extensive time working at a computer keyboard and monitor
  • Additional requirements include working with documents in large file cabinets, creating documents for packing and shipping, and other light physical lifting and moving of materials
  • 6 month contract to hire