Research Regulatory Compliance Specialist

Position Summary:
The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Research Regulatory Compliance Specialist to join our team. The TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. The Specialist will assist with and oversee regulatory submissions, provide staff training and guidance and serve as a regulatory compliance expert to develop and implement policies for the Center. The specialist will collaborate with Center leadership, investigators and their research teams, and other involved institutional groups to ensure adherence to institutional, state and federal regulatory processes and policies.
Key Responsibilities:

• Provides oversight and guidance for regulatory projects within the TNC ensuring effective set-up, operations, and close-out of all assigned projects. Includes study matters, study processes, and study needs / timelines. Identify project risks and provide solutions/corrective action.
• Assists with submission document development (e.g. consent forms), IRB and FDA applications.
• Provides project management and study start up support for select clinical research projects.
• Ensures execution and maintenance of all regulatory reporting, documentation, and filing for assigned projects, including following protocol and regulatory requirements.
• Prepares and/or oversees regulatory correspondences with internal stakeholders, Sponsors, Data Safety and Monitoring Boards, FDA, sub-contracts, vendors, and other regulatory bodies as applicable.
• Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials.
• Develops and oversees execution of audit plans and performs audit/site visits for the purpose of reviewing data/regulatory information and querying teams/sites regarding data and regulatory issues.
• Assist in the development and implementation of internal processes and policies.
• Opportunity to contribute to additional projects; for example, community outreach programs and career fairs.
• Performs other assignments as required.

Minimum Qualifications
Education:

• A Bachelor's Degree in a Healthcare field is preferred.

Experience:

• Two years of directly related job experience.