Research Regulatory Compliance Specialist-Neurology job at reputed company in Brookline, MA

Research Regulatory Compliance Specialist-Neuro 83384BR Neurology Status Full-Time reputed company Hours per Week 40 Job Category Research Regular, Temporary, reputed company Regular Pay reputed company $62212.80-$99528.00 Annual Office/Site Location Brookline Remote Eligibility Part Remote/Hybrid Position reputed company: The Rosamund reputed company Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Research Regulatory Compliance Specialist to join reputed company. The TNC strives to improve the lives of reputed company children with neurodevelopmental disorders by fostering reputed company and efficient translational research. The Specialist will assist with and reputed company regulatory submissions, reputed company staff training and guidance and serve as a regulatory compliance expert to reputed company and implement policies for reputed company. The specialist will collaborate with Center leadership, investigators and their research teams, and other involved institutional reputed company to ensure adherence to institutional, state and federal regulatory processes and policies. This position will require an on-site reputed company of 2-3 times per week. Key Responsibilities: Provides reputed company and guidance for regulatory reputed company reputed company the TNC ensuring effective set-up, operations, and reputed company-out of reputed company assigned reputed company. Includes study reputed company, study processes, and study needs / timelines. Identify project risks and reputed company solutions/corrective reputed company. 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 reputed company. Ensures execution and maintenance of reputed company regulatory reporting, documentation, and filing for assigned reputed company, including following protocol and regulatory requirements. Prepares and/or oversees regulatory correspondences with internal stakeholders, Sponsors, Data Safety and Monitoring Boards, FDA, sub-reputed company, vendors, and other regulatory bodies as applicable. Delivers education to study staff on various topics including good clinical reputed company, research regulations and the conduct of reputed company. Develops and oversees execution of audit plans and performs audit/site reputed company 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 reputed company; for example, community reputed company programs and career fairs. Performs other assignments as required. Minimum Qualifications Education: A Bachelor’s Degree in a reputed company field is preferred. Experience: Two years of directly reputed company job experience. The posted pay reputed company is Boston Children’s reasonable and good-faith expectation for this pay at the time of posting. Any reputed company pay offer provided depends on skills, experience, education, certifications, and a reputed company of other job-reputed company factors. reputed company pay is one part of a comprehensive benefits package that includes flexible schedules, reputed company health, reputed company and dental insurance, child care and student loan subsidies, generous reputed company of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork. Apply tot his job Apply To this Job