Research Regulatory Compliance Specialist-Neuro

Research Regulatory Compliance Specialist-Neuro Boston Children's Hospital, United States about 12 hours ago

Location:

Brookline, MASSACHUSETTS Details

Posted:

Unknown

Location:

Salary:

Summary:

Summary here. Details

Posted:

31-Mar-26

Location:

Brookline, Massachusetts

Salary:

62,212.80 - 99,528.00

Categories:

Staff/Administrative

Internal Number:

151195831

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.

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. The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes 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, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork. Create a Job Match for Similar Jobs About Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age. Connections working at Boston Children's Hospital More Jobs from This Employer main.hercjobs.org/jobs/22161931/research-regulatory-compliance-specialist-neuro Return to Search Results Similar Positions Senior Research Compliance Specialist, Boston College, United States, about 7 hours ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g... Senior Research Associate Whitney Laboratory, Boston College, United States, about 19 hours ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g... Administrative & Program Specialist (Dean Of Students Office), Boston College, United States, 15 days ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g... Research Associate School Of Social Work, Boston College, United States, 9 days ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g... Facilities Manager - Science & Research Laboratories, Boston College, United States, 15 days ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g... Administrative & Program Specialist (Career Center), Boston College, United States, 15 days ago Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,654 full-time undergraduates and 5,072 g...