Clinical Research Coordinator II

Updated: December 4, 2017
Job ID: 213355
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a Clinical Research Coordinator II for the Infectious Disease Clinical Research Program (IDCRP) at the Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Responsibilities are to perform clinical research and participant treatment in conjunction with one or more specified clinical research protocols and will be supervised by either Clinical Site Manager or designee.

Responsibilities:

  1. May serve as the lead CRC for at least one research protocol.
  2. Interviews participants for protocols and collects and analyzes appropriate data for recruitment purposes, determine participant commitment and obtains informed consent.
  3. Reviews new participant records and screens participants for eligibility for participating in research protocol.
  4. Coordinates the dispensing of appropriate drugs/devices/infusions to participants as specified in protocols. When applicable and training requirements are met, draws blood and obtains other specimens as specified in protocols.
  5. Educates participants about the research protocol, their roles in the protocols, and any other vital information and acts as a research case manager for the participants where appropriate.
  6. Assists research team to identify problems in the research design or analysis methodology and trends in participant reactions to treatment.
  7. Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data.
  8. Identifies clinically significant findings and results that warrant prompt action to the Principal Investigator and prepares UP/AE reports per protocol.
  9. Maintains weekly/monthly status reports on all participants.
  10. Acts as a liaison between participants and research investigators and serves as a resource for the participants.
  11. May prepare and upload site documents to the eIRB system.
  12. Prepares and maintains manual and computerized data in participant research records according to prescribed standards.
  13. Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads and descriptive data from participant research records to be used in research reports.
  14. Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practice.
  15. Assists with monitoring audits/visits for protocols.
  16. Travels to/from their assigned workplace to support protocols as needed.
  17. Schedules participants for appointments and visits.
  18. Reviews and provides input to protocols and related documents during development and for modifications.
  19. Performs other duties as assigned.

Required Knowledge, Skills, and Abilities: Knowledge of procedures and techniques necessary for performing research tasks; ability to learn and become proficient in data acquisition and clinical responsibilities related to research protocols; Knowledge of federal and local regulations and policies pertinent to research involving human subjects; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels.

Minimum Education/Training Requirements: Bachelor's degree in a scientific discipline required.

Minimum Experience: 2 to 4 years’ experience working with human subject research protocols.

Physical Capabilities: Long periods of sitting and standing; some bending, lifting, and walking; escorting participants and carrying light items; may encounter participants who are confused, agitated, or abusive.

Required Licenses, Certification or Registration: Certified in basic cardiac life support required; certified as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP), and/or Clinical Research Associate (CCRA) preferred. Must be able to obtain a Department of Defense Common Access Card.

Work Environment: Laboratory, office or clinical/hospital environment; possible evening and/or weekend hours. If worksite requires work on a military base, a background investigation is necessary.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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