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Job Details

Regulatory Compliance Manager/Coordinator

Silver Spring, MD, United States

Posted on
Feb 01, 2023

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Job Information
Regulatory Compliance Manager/Coordinator
Silver Spring
Type of Requisition:
Clearance Level Must Be Able to Obtain:
Interim Secret
Job Family:
Regulatory Affairs
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.
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.
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).
● 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
COVID-19 Vaccination: GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

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