Regulatory Affairs Manager

The Regulatory Affairs Manager will report directly to the Senior Regulatory Affairs and Data Manager. The Regulatory Affairs Manager will oversee assigned regulatory team staff, oversee and submit regulatory lifecycle actions for all projects within the program, serve as principal administration regulatory liaison for projects, develop and maintain recordkeeping systems and procedures, oversee and prepare essential research documents, oversee and perform submissions to the IRB, and provide audit support.

About the Program:

The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) 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), 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.

About the Position:

The Regulatory Affairs Manager will report directly to the Senior Regulatory Affairs and Data Manager. The Regulatory Affairs Manager will oversee assigned regulatory team staff, oversee and submit regulatory lifecycle actions for all projects within the program, serve as principal administration regulatory liaison for projects, develop and maintain recordkeeping systems and procedures, oversee and prepare essential research documents, oversee and perform submissions to the IRB, and provide audit support.

***PLEASE NOTE: This is a remote position. Commutable distance within the Rockville Metro area is preferred. A thorough government background check will be required.

Job Responsibilities:

• Ensure program-wide research regulatory lifecycle compliance.

• 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).

• 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.

• Assist with the development of essential research documents such as protocols, informed consent documents, HIPAA authorizations, case report forms, etc.

• Create and maintain complete electronic regulatory binders for each study in the program.

• Obtain and maintain personnel documents, including CVs, medical licenses, COIs, and human subject research training completion reports, as appropriate.

• Negotiate, coordinate, and track the use of IRB reliance agreements, as appropriate.

• Promote safety and confidentiality of research participants at all times

• Stay up to date on all required human subjects research training.

• 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 program staff. Provide direction, address questions, and provide skills/knowledge transfer.

• Provide regular summaries and updates to Senior Regulatory Affairs & Data Manager.

• Plan and facilitate individual and team meetings.

• Lead performance review processes for assigned program staff.

• In collaboration with Geneva People Operations and Senior Regulatory Affairs and Data manager, conduct counseling and corrective action, as appropriate.

Qualifications:

• Bachelor’s degree or equivalent work experience required.

• Regulatory and IRB submission experience required.

• 3-5 years military/DoD research experience preferred.

• 3-5 years’ clinical research experience preferred.

• 3-5 years’ non-profit, research, or healthcare experience 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

The Geneva Foundation is an equal opportunity employer and prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.