Regulatory Affairs Coordinator

Location

Bethesda, MD | United States

Job description

Join the HJF Team!

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. 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.  Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

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.

This position will be in support of the Office of Regulatory Affairs & Research Compliance at the Home Office in Bethesda, MD. 

• 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.

Education and Experience

• Bachelor’s Degree is required.
• Minimum of 0-2 years of experience required.

Licenses and Certifications

• Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred but not required.

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.
• Ability to obtain and maintain a T3 Secret Clearance. 

Physical Capabilities

• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position will take place primarily in an office setting. 

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Job tags

Salary