Research Regulatory Compliance Specialist
1 day ago
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. 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. Compensation and Benefits The posted pay range is Boston Children's reasonable and good-fate 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. #J-18808-Ljbffr
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Brookline, United States Boston Children's Hospital Full timePosition 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...
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Brookline, United States Boston Children's Hospital Full timeA leading healthcare institution in Brookline is seeking a dynamic Research Regulatory Compliance Specialist to manage regulatory submissions and ensure compliance within the Translational Neuroscience Center. This role requires collaboration with investigators and oversight of projects involving neurodevelopmental disorders. Candidates should have a...
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Brookline, United States ARMA International Full timeA leading healthcare research institution in Massachusetts is seeking a Research Regulatory Compliance Specialist. This role involves overseeing regulatory submissions, providing education on clinical trial regulations, and ensuring compliance with institutional and federal requirements. The ideal candidate will have a Bachelor's degree in a healthcare field...
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Regulatory Compliance Director
6 days ago
Brookline, United States Dana-Farber Cancer Institute Full timeOverview The Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI’s ethical standards, federal and state healthcare laws, payer requirements and...
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Regulatory Compliance Director
2 weeks ago
Brookline, MA, United States Dana-Farber Cancer Institute Full timeThe Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI’s ethical standards, federal and state healthcare laws, payer requirements and internal...
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Regulatory Compliance Director
2 weeks ago
Brookline, MA, United States Dana-Farber Cancer Institute Full timeThe Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI’s ethical standards, federal and state healthcare laws, payer requirements and internal...
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Regulatory Compliance Director
3 weeks ago
Brookline, MA, United States ARMA International Full timeThe Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI’s ethical standards, federal and state healthcare laws, payer requirements and internal...
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Healthcare Regulatory Compliance Leader
3 weeks ago
Brookline, MA, United States ARMA International Full timeA leading cancer research organization in Massachusetts is seeking a Regulatory Compliance Director to oversee compliance programs and ensure adherence to regulations. Before applying for this role, please read the following information about this opportunity found below. The ideal candidate will have extensive regulatory expertise and leadership experience,...
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Regulatory Coordinator
1 day ago
Brookline, United States Dana-Farber Cancer Institute Full timeThe Regulatory Coordinators (RC) works under the direction of the Thoracic Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and/ or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and...
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Brookline, United States Dana-Farber Cancer Institute Full timeA leading cancer research organization in Massachusetts seeks a Regulatory Coordinator to manage regulatory compliance for clinical studies. This role involves submitting protocol applications, maintaining regulatory files, and engaging with study teams and regulatory bodies. Ideal candidates will have a relevant Bachelor's degree and some experience in...
