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At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included. 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. This position will require an on-site presence of 2-3 times per week.
Job Responsibility:
Provides oversight and guidance for regulatory projects within the TNC ensuring effective set-up, operations, and close-out of all assigned projects
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
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
Requirements:
Bachelor’s Degree in a Healthcare field is preferred
Two years of directly related job experience
What we offer:
flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement