Regulatory Affairs Specialist (Hybrid) – Vice President – Research (Hybrid)

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. This position will be in support ofHuman 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 is seeking a Regulatory Affairs Specialist 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,andeducational activities. 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 toresearch 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,IRBmembers,investigators,facultyand 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,DoDregulations and University goals and policies. Performs other functions as directed by the Director,Office of Research Compliance. Supervisor y Responsibilities Works under the supervision of the Director, Office of Research Compliance. Work is reviewed in terms of being correct, complete, timely, and in conformance with all DoD and Federal regulations and USUHS policies and procedures. Completed work is also reviewed critically outside the incumbent’s immediate office by the Chair and other members of the IRB, by the Vice President for Research, by the Institutional Office, and by other officials and personnel involved with human subjects research. Physica l Capabilities Work is sedentary, although there is some standing or carrying of office supplies and materials, such as large binders and folders. The work requires some walking but there are no special physical demands. Required Knowledge, Skills and Abilities 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. Possesses good interpersonal skills in order to express complex ideas, convey critical information, resolve conflict and foster teamwork and productive working relationships. Possesses sufficient knowledge of computer use and applications including word processing. Programs, spreadsheets and electronic submission systems and/or databases to log and track all information pertinent to human research protections. Qualifications Work Environment This position will take place primarily in an office setting. Education and Experience Bachelor’s Degree is required. Minimum of 3-5 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.

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