Research Regulatory Compliance Specialist
82351BR
Neurology
Status
Full-Time
Standard Hours per Week
40
Job Category
Research,
Regular, Temporary, Per Diem
Regular
Pay Range
$62,2130.00-$99,528.00 Annual
Office/Site Location
Brookline
Remote Eligibility
Part Remote/Hybrid
Job Posting Description
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.
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.
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.
Boston Children’s Hospital offers competitive compensation and unmatched benefits for eligible positions; including 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.
Boston Children’s Hospital is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, gender, sexual orientation, pregnancy, national origin, ancestry, ethnicity, age, disability, military or veteran status or any other classification protected by law in hiring, promotion, compensation and other terms and conditions of employment. Boston Children’s Hospital collects and maintains information regarding gender, race, and ethnicity for equal opportunity compliance purposes. Boston Children’s Hospital also is subject to various government recordkeeping and reporting requirements for the administration of civil rights laws and regulations.
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