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Boston Children's Hospital · 2 days ago

Research Regulatory Compliance Specialist-Neuro

Brookline, MA

Full-time

Hybrid

Entry, Mid Level

$62K/yr - $100K/yr

2+ years exp

Boston Children's Hospital is seeking a dynamic and innovative Research Regulatory Compliance Specialist to join their team. The role involves overseeing regulatory submissions, providing staff training, and serving as a compliance expert to ensure adherence to regulatory processes.

Health CareHospitalMedical

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