Regulatory Affairs Coordinator (Hybrid) – Regulatory Affairs (2 of 2) (REGUL003374)
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. U.S. citizenship required for this position.
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.
NOTE: All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
- 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.
- 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.
- Ensures required protocols are registered and up to date in clinicaltrials.gov.
- 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.
- Maintains effective liaison with research staff and PIs in assigned portfolio.
- Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
- Review and process research participant travel and reimbursement and request for clincards.
- Maintain excellent customer service with the research staff under the assigned portfolio.
- 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 and familiarity with the Institutional Review Board (IRB) and human subjects protection training required.
- Knowledge of federal and local regulations and policies pertinent to research, ideally involving human subjects, 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 in a scientific discipline or a related field is required.
Minimum Experience/ Training Requirements: Minimum of 0-2 years of relevant work experience is required.
Required Licenses, Certification or Registration: CCRA, CCRP, or CCRC is preferred. Training in human subject’s protection in research preferred.
Work Environment: Set in an office work environment. The incumbent may be 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.
Work Arrangement: Hybrid to start.
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.