Regulatory Compliance Manager/Coordinator

Seize your opportunity to make a personal impact as a Regulatory Compliance Manager/Coordinator. GDIT is seeking to fill a Regulatory Compliance Manager/Coordinator position for the staff and customers of the WRAIR in support of the Medical Standards Analytics and Research (MSAR) and Statistics and Epidemiology Branch Research Programs. The position is located at Walter Reed Army Institute of Research (WRAIR) in Silver Springs, MD.

At GDIT, people are our differentiator. Join us on the frontlines of health IT and make an impact on the health of our nation.

HOW A REGULATORY COMPLIANCE MANAGER/COORDINATOR WILL MAKE AN IMPACT:

• Manages and coordinates project activities and monitors for compliance with applicable DOD rules and regulations.
• Develops and updates Standard Operating Procedures (SOPs) to ensure that the MSAR program and S&E branch are compliant with DOD, DHA, Army, MRDC, WRAIR and Human Subject Protection Branch (HSPB) regulatory requirements.
• Ensures regulatory compliance and the development and maintenance of regulatory documentation.
• Provides administrative support to include reference library updates, website maintenance, and knowledge product reviews. 
• Provide substantial coordination and interface with other military and civilian collaborators.
• Maintains multiple protocol books, chronicle manuscript preparation, tracking and filing system.
• Provides direct functional support to ensure timely submission of protocols, amendments, continuing review and closeout reports and other regulatory documents in accordance with WRAIR IRB/HSPB timelines.
• May travel to meetings and conferences when necessary.

WHAT YOU'LL NEED:

• Bachelor’s Degree in Public Health. Preferred: Master’s degree in Public Health.
• Five (5) years of successful coordination of and compliance with WRAIR regulations. Preferred: Seven (7) years of successful coordination of and compliance with WRAIR regulations.
• Possesses extensive expertise and experience in preparation of and assistance with WRAIR DUA/DSAs, MOAs, MOUs, MFRs, S&E branch memos, operational and human subject research protocols, their amendments, and continuous review reports along with other regulatory documents.
• Excellent writing and communication skills for performing medical literature searches, writing scientific summaries, editing, executing quality control checks of scientific knowledge products, corresponding with senior leaders, and managing internal and public facing websites.
• Extensive knowledge of and experience with managing GFE inventories, WRAIR in-processing, out-processing, badge and CAC card acquisition and renewals, and assisting in acquiring appropriate software, hardware, and supplies.
• U.S. citizenship required.
• Ability to secure a Public Trust clearance- Automated Data Processing Level II (ADP-II)/National Agency Check with Law and Credit (NACLC).

GDIT IS YOUR PLACE:
● 401K with company match
● Comprehensive health and wellness packages
● Internal mobility team dedicated to helping you own your career
● Professional growth opportunities including paid education and certifications
● Cutting-edge technology