Regulatory Affairs Specialist

Overview Join the HJF Team! HJF is seeking a Regulatory Affairs Specialist to support Compliance Operations particularly the Institutional Review Board (IRB) operations and functions within the Human Research Protections Program (HRPP) of the Office of the VP of Research located at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD.

HJF provides scientific, technical, and programmatic support services to USU. This position reports to the Director, Office of Research Compliance in administering all University activities related to human research protections, research policy and development and educational activities. 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. This position supports the Human Research Protections Program (HRPP) within the Office of the VP of Research located at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD. Responsibilities Responsibilities As a member of the Compliance team, be able to conduct a pre-IRB review of submissions to an electronic system to ensure that all research and related activities outlined in the submission are in accordance with ethical guidelines and applicable Federal regulations, policies and procedures.

Make recommendations on the appropriate type of review necessary to obtain compliance approval for the research and triage studies to the appropriate official or review body. Coordinate administrative activities before, during and after IRB meetings to facilitate the efficient review and approval of research protocols by the IRB. Competent in oral and written communication methods including writing meeting minutes, memos and official letters that have appropriate grammar, spelling, and business correspondence formats.

Participate in analyzing process and performance activity, trends, and outcomes related to research activity and compliance. Participate in developing human subject protection and related policies for the research community in matters related to the ethical conduct of research involving human subjects and other relevant areas as may be required to meet federal, state, DoD regulations and University goals and policies. Participate in developing educational activities for the research community and facilitate or conduct training sessions for Human Research Protections Program staff, IRB members, investigators, faculty and students in matters related to the ethical conduct of research involving human subjects and other relevant areas as may be required to meet federal, state, DoD regulations and University goals and policies.

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 is required.

Scientific background preferred. Minimum of 3-5 years of experience required. Clinical Care experience is a plus Licenses and Certifications Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) Preferred.

Required Knowledge, Skills and Abilities Excellent communication, writing and interpersonal skills to express complex ideas, convey critical information, resolve conflict and foster teamwork and productive working relationships. Must be a self-starter, able to work independently, and able to multi-task. Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, and electronic submission systems and/or databases to log and track all information pertinent to human research protections.

Must possess a working knowledge of all DoD Instructions and Federal statutes and regulations pertaining to human subject's research protections. Understanding of how policy is developed, approved, and implemented. Understanding of organization and presentation of structured material to educate relevant target audiences in policy and process.

Familiarity with DoD Instruction 3216.02 Physical Capabilities Ability to stand or sit at a computer for prolonged periods. Work Environment This position will take place primarily in an office setting. Some HJF employees are required to be fully vaccinated against COVID-19.

Proof of vaccination or an approved religious or medical accommodation will 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.