Regulatory Affairs Coordinator
The Henry M. Jackson Foundation for the Advancement of Military Medicine
Summary
HJF is seeking a Regulatory Affairs Coordinator to be 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). This is the first level in the Regulatory Affairs series.
Job description
This position will be in support of the Clinical Regulatory Affairs & Compliance Office at HJF Home Office in Bethesda, MD.
Responsibilities
- 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.
- 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 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.
- 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.
- Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective deadlines.
- 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.
Qualifications
Education and Experience
- Bachelor’s Degree in a science related field required.
- Minimum of 0-2 years of experience required.
- At least 1 year of relevant experience preferred.
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, be able to work independently, and able to multi-task.
- Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and E-mail.
- US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
Physical Capabilities
Lifting: Requires lifting materials up to 25 lbs.
Licenses and Certifications
Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.
Work Environment
This position will take place primarily in an office setting.
Requirements
- Bachelor’s Degree in a science related field required.
- Minimum of 0-2 years of experience required.
- At least 1 year of relevant experience preferred.
- 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, be able to work independently, and able to multi-task.
- Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and E-mail.
- US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
- Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.
Benefits
- Medical, Dental & Vision
- Health Savings Plans
- Retirement Plans
Company overview
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a global nonprofit organization dedicated to advancing military medicine through scientific research, education, and clinical innovation. Founded in 1983 and named after the late U.S. Senator Henry M. "Scoop" Jackson, HJF serves as a critical bridge between the military medical community and civilian research institutions. The foundation provides essential administrative, programmatic, and logistical support to military medical researchers, enabling groundbreaking discoveries in areas such as combat casualty care, infectious diseases, psychological health, and rehabilitation medicine. HJF operates in partnership with the Uniformed Services University of the Health Sciences, the Department of Defense, and other federal agencies, managing hundreds of research programs worldwide. With a focus on translational research, the foundation accelerates the development of medical solutions that benefit both military personnel and civilian populations, while maintaining the highest standards of scientific integrity and ethical conduct.