Regulatory Affairs Coordinator

Updated: March 25, 2020
Job ID: 215806
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Regulatory Affairs Coordinator to support the Pediatrics Department located at the Uniformed Services University (USU). HJF provides scientific, technical and programmatic support services to the Pediatrics Department. 

The incumbent will be responsible for assisting in the compliance of Foundation 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:

  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.
  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 relationship with research staff, Principal Investigators and Institutional Review Boards’ (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of protocols 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. Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective deadlines.
  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: Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA;  excellent communication and writing skills, interpersonal and organizational skills; must be a self-starter and be able to work independently; must be able to 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 required. 

Minimum Experience/ Training Requirements: 0-2 years or relevant experience required. 

Work Environment: Office Environment 

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a 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.  

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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