Regulatory Affairs Assistant

Updated: Yesterday
Job ID: 213884
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Regulatory Affairs Assistant to support the Regulatory Affairs Department located at the Corporate Headquarters in Bethesda, Maryland. Responsible for assisting the Regulatory Affairs Coordinators(s) and Specialist(s) in oversight of the Foundation’s Human Use and Animal Use Programs.

Responsibilities:

  1. Assist 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 developing and maintaining a regulatory database and tracking database to include data entry, queries, and reports. Maintains up to date regulatory files for those protocols assigned.
  3. Assists with the review of research personnel training files to ensure that participating appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, and shipping dangerous goods have been completed.
  4. Assist with the review of research files to ensure GCPS have been met, informed consent forms have been completed appropriately, and that the principal investigator is maintaining the necessary regulatory files and subject research documents.
  5. Maintains effective liaison with IRBs, IACUCs, and IBCs where Foundation research is being conducted. 
  6. Assists the Regulatory Affairs Coordinator(s), and Specialist(s) with compliance, regulatory, and research training activities for principal investigators and research personnel.
  7. Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
  8. Completes other projects as needed.

Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA; excellent communication, 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, and E-mail.

Minimum Education/Training Requirements: Bachelor’s degree in a scientific discipline or a related field is desired.  Must have completed training in human subjects protection in research.

Minimum Experience: 1 to 2 years-related experience in the area of human use, IRB, clinical research or laboratory animal research.

Physical Capabilities: Must be able to utilize computer for lengthy periods of time; perform routine filing; standing for lengthy periods of time utilizing Xerox machine for copying documents; must be able to travel to various sites occasionally.

Required Licenses, Certification or Registration: CCRA, CCRP, or CCRC preferred but not required. Must be US Citizen and able to obtain a CAC card.

Work Environment: Office environment.  In the absence or at the request of the Regulatory Affairs Specialist, may be required to conduct site visits to various military and civilian hospitals and/or research labs where Foundation supported research is being conducted and must be able to travel to those sites.  Must be available for local travel also.  Travel can be anticipated about 10% of the time.

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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