United States onlyThe Regulatory Affairs Manager will oversee assigned regulatory team staff, navigate submission/approval pathways, lead the development of new protocol submissions and essential research documents, oversee and submit regulatory lifecycle actions, develop and maintain recordkeeping systems and procedures, advise study staff on good research practices, provide monitoring support, and ensure research lifecycle compliance of all assigned projects.
Experience with FDA-regulated clinical trials highly desired. Previous experience in research conduct preferred.
***PLEASE NOTE: This is a partially-remote position. Must live within a commutable distance of the Bethesda, MD area for reporting to site two days per week. A thorough government background check will be required.
About the Program:
The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) Program was established to support the execution of clinically relevant research to advance the care of service members with non-combat related musculoskeletal injury (MSI). Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness. The MIRROR portfolio currently consists of 65 active projects.
Salary:
$90k- $105k/annually. Salaries are determined based on several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.
Job Responsibilities:
Ensure research regulatory lifecycle compliance of assigned projects.
Serve as programmatic subject matter expert (SME) for regulatory affairs actions, compliance with federal and military-specific regulations, good documentation practices (GDP), and general good research practices (GRP).
Advise study team members on good research practices and answer ad hoc study conduct-related questions that arise throughout the research lifecycle.
Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports, etc.
Lead the development of initial submission packages for new projects. Assist with the development of essential research documents such as protocols, informed consent documents, HIPAA authorizations, etc.
Create and maintain complete electronic regulatory binders for each study in the program.
Negotiate, coordinate, and track the execution of IRB reliance agreements, as appropriate.
Promote safety and confidentiality of research participants at all times.
Develop and disseminate live trainings, educational materials, templates, and SOPs to program investigators and study team members.
Management Responsibilities:
Supervise the day-to-day activities of assigned regulatory affairs program staff. Provide direction, address questions, and provide skills/knowledge transfer. Oversee workload and productivity.
Provide regular summaries and updates to Program Supervisor.
Plan and facilitate individual and team meetings.
Lead performance review processes for assigned regulatory affairs staff.
In collaboration with Geneva People Operations and Program Supervisor, conduct counseling and corrective action, as appropriate.
Qualifications:
Bachelor’s degree or equivalent work experience required.
Regulatory Affairs and IRB submission experience required.
3-5 years’ clinical research experience required.
3-5 years military/DoD research experience preferred.
3-5 years experience in FDA-regulated clinical trials preferred.
1-2 years management/supervisory experience strongly preferred.
Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation skills to staff required.
Ability to exercise independent judgement in a fast-paced, high-pressured environment, accommodate strict deadlines, and manage multiple projects required.
Must demonstrate high quality oral and written communication skills.
Must be organized, have strong attention to detail, and possess a positive, friendly and professional demeanor.
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner.
