Regulatory Compliance Specialist
4 weeks ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Weill Cornell Medicine. As a key member of our clinical research team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for clinical trials.
Key Responsibilities
* Coordinate all aspects of protocol submission for research projects
* Prepare and submit all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board (IRB) and ancillary committees
* Work with the research team to facilitate the enrollment of research subjects in compliance with established regulations and guidelines
* Review and confirm subject eligibility and regulatory compliance for enrollment
* Submit eligibility exceptions to the IRB
* Perform central subject registration for specified research studies
* Report all Serious Adverse Events (SAEs) to the Institutional Review Board and other agencies, as required
* Prepare and submit all regulatory documents to sponsor and/or contract research organization (CRO)
* Ensure maintenance of up-to-date regulatory records and compliance with industry deadlines
Requirements
* Bachelor's Degree in a related field
* Approximately 2 years of prior clinical research experience in a healthcare setting
* Master's degree in a related field can be substituted for experience
* Demonstrated knowledge and understanding of clinical research
* Certified Clinical Research Professional (CCRP) Preferred
What We Offer
* Competitive salary and benefits package
* Opportunity to work with a leading academic medical center
* Collaborative and dynamic work environment
About Weill Cornell Medicine
Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists. Our doctors and scientists are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies.
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