Regulatory Specialist

1 day ago


New York, New York, United States Weill Cornell Medical College Full time
Job Title: Regulatory Specialist

We are seeking a highly skilled Regulatory 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.

Key Responsibilities:
  • Coordinate all aspects of protocol submission for research projects
  • Prepare and submit necessary documents to the Clinical Science Evaluation Committee (CSEC), Institutional Review Board (IRB), and ancillary committees
  • Work with the research team to facilitate 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
  • Provide training to junior and new staff on subject registration and regulatory processes and procedures
  • Maintain and disseminate accurate listings of active and potential studies to participating investigators
  • Serve as the resource for detailed information on assigned protocols and other investigational research activities
  • Provide assistance for specified investigator-initiated trials
  • Coordinate site visits and audits of clinical trials
  • Attend conferences regarding clinical trials and disseminate information to clinical staff
  • Maintain electronic and hard copy files
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
Weill Cornell Medicine is an Equal Employment Opportunity Employer.

Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to protected status, including race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.



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