Clinical Research Coordinator II

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Updated: May 16, 2019
Job ID: 213725
Status: Full-Time
Regular/Temporary: Regular
Location: Silver Spring, MD, United States

Join the HJF Team!

The position will serve as a Clinical Research Coordinator II to support the Clinical Trials Center (CTC) within the Translational Medicine Branch (TMB) at Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

The incumbent provides clinical research support services to conduct federally regulated research required to develop new medical products for the Warfighter.  Most products are drugs, devices, or biologics, but research products may include new information and doctrine.

Support services will include conducting clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP).  All of the work to support this research must be performed in accordance with the Federal, Department of Defense (DoD), and Command laws, regulations, and policies. Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings.

Responsibilities:

  1. The Contractor shall coordinate protocols by organizing and prioritizing all activities associated with conducting phase 1, 2 and 3 studies within a military setting, review and understand protocol, ensuring applicable regulations and guidelines are followed.
  2. The Contractor shall coordinate space and supplies with appropriate personnel, recruit volunteers for the studies, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail and test article accountability.
  3. The Contractor shall document, to include gathering, preparing and maintaining appropriate information per applicable FDA regulations and ICH guidelines, source and case report forms, participant rosters, SOPs.
  4. The Contractor shall be experienced, skilled and qualified in nursing procedures including phlebotomy and the administration of experimental vaccines as per specific protocol guidance in accordance with the 21CFR 11, 50, 54, 56, 312, and 314.

Required Knowledge, Skills, and Abilities: Knowledge of clinical research procedures; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels. The candidate should be well-organized; ability to follow detailed instructions; ability to handle multiple tasks; ability to meet deadlines of projects; ability to facilitate communication among supervisors, team members, and peers.

Minimum Education/Training Requirements: Bachelor’s Degree in related field; biological sciences, public health, kinesiology, or bioengineering.

Minimum Experience: 2 to 4 years human subject clinical research experience. Experience working with IRB protocols and/or data management highly desirable.

Background Requirement: Eligibility to obtain DoD Common Access Card (CAC) required.

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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