Bethesda, Maryland

Join the HJF Team!

HJF is seeking a Regulatory Affairs Coordinator to support the Regulatory Affairs Department, located at the HJF Home Office in Bethesda, MD. HJF provides scientific, technical, and programmatic support services to military medical research programs. US citizenship is required.

This position is responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). Responsibilities includes identifying problems and works with senior staff to implement solutions. The incumbent will report directly to the Director, Office of Regulatory Affairs & Research Compliance.

Responsibilities:
  1. Assists with the review of protocols, grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
  2. Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports. Prepares regulatory binders (paper and electronic) for protocols assigned in their portfolio to be audit ready.
  3. Ensures required protocols are registered and up to date in clinicaltrials.gov.
  4. Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed.
  5. Maintains effective liaison with research staff and PIs in assigned portfolio.
  6. Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
  7. Review and process research participant travel and reimbursement and request for clincards.
  8. Maintain excellent customer service with the research staff under the assigned portfolio.
  9. 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:
  • Must have knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA. Familiarity with Institutional Review Board (IRB) activities.
  • Experience submitting NDA or deveice applications to the FDA preferred.
  • Excellent communication and writing skills, interpersonal and organizational skills.
  • Must be a self-starter, able to work independently and multi-task.
  • Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and e-mail.

Minimum Education: Bachelor's degree in a scientific discipline or a related field is required.

Minimum Experience/ Training Requirements:0-2 years of related experience in human use, IRB, clinical research or laboratory animal research required. At least 1 year of experience strongly preferred.

Required Licenses, Certification or Registration: CCRA, CCRP, or CCRC is preferred. Must have completed training in human subjects protection in research.

Work Environment: Office environment; required to conduct site visits to various military and civilian hospitals and/or research labs where HJF supported research is being conduct. Site visits includes local travel as necessary.

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.

Similar jobs