Regulatory Compliance Specialist
4 weeks ago
At Hackensack Meridian Health, we strive to provide exceptional patient care and advance our mission to transform healthcare. As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures.
Key Responsibilities:- Ensure compliance with regulatory requirements for assigned clinical trials
- Serve as a regulatory liaison to internal and external investigators, sponsors, and regulatory agencies
- Organize and maintain regulatory binders and ensure ongoing compliance of study-related documentation
- Review and prepare clinical study documentation for submission to IRBs and regulatory agencies
- Participate in the development of procedures to ensure regulatory compliance
- BA/BS diploma/degree in science or healthcare field or minimum of 2 or more years of experience in a related area
- Proficiency in Microsoft Office Suite and/or Google Suite platforms
- Minimum of 2 or more years of extensive experience in research, including clinical research, regulatory, auditing, and interactions with an IRB
Why Join Our Team?
As a Regulatory Affairs Specialist at Hackensack Meridian Health, you will have the opportunity to work in a dynamic and collaborative environment, contributing to the advancement of healthcare and the well-being of our patients.
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Regulatory Compliance Specialist
4 weeks ago
Paramus, New Jersey, United States Hackensack Meridian Health Full timeRegulatory Specialist Job DescriptionAt Hackensack Meridian Health, we are committed to delivering high-quality patient care and advancing our mission to transform healthcare. As a Regulatory Specialist, you will play a critical role in ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies...
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Regulatory Compliance Specialist
4 weeks ago
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