Bethesda, Maryland

Join the HJF Team!

HJF is seeking a Regulatory Affairs Assistant to support the Murtha Cancer Center Research Program (MCCRP), located at the Rockledge office in Bethesda MD. HJF provides scientific, technical and programmatic support services to MCC. US Citizenship is required.

The incumbent will be responsible for assisting in the compliance of MCCRP research studies with applicable regulations for human subjects' research in collaboration with MCCRP professional staff.

Responsibilities:
  1. Assists with the preparation of regulatory documents for MCCRP clinical research projects and FDA-regulated clinical trials, including research protocol preparation, Institutional Review Board submissions and annual progress reports, as needed. (25%)
  2. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC and HJF. (20%)
  3. Collects and monitors required research training certifications and other study personnel documents for MCCRP investigators and study team members. (20%)
  4. Provides quality control for research study documents including informed consent documents and case report forms. (15%)
  5. Performs data entry for research projects and manages databases as needed. (10%)
  6. Performs tasks associated with the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; tracks MCCRP scientific publications and provides regular reports to institutional leadership. (10%)
  7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities:
  • Knowledge of human subjects' research regulations required
  • Demonstrated experience in regulatory affairs
  • Strong organizational skills and attention to detail
  • Excellent communication and interpersonal skills
  • Strong writing skills.
  • Ability to utilize computer applications packages, such as, MS Word, Excel, PowerPoint, Adobe Acrobat.
  • Experience with electronic institutional review boards (eIRBs) strongly preferred.

Minimum Education: Associates degree is required. Bachelor's degree is preferred.

Minimum Experience/ Training Requirements:3-5 years of experience is required.

Work Environment: Set in an office work environment

Background/Security: U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance and Common Access Card (CAC).

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

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

Bethesda, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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