Regulatory and Clinical Trials Specialist

4 weeks ago

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

We are seeking a highly skilled Regulatory and Clinical Trials Specialist to join our team at Weill Cornell Medical College. The successful candidate will be responsible for managing the development of investigator-initiated clinical trials and ensuring compliance with federal, state, and institutional regulations.

Key Responsibilities:
  • Manage the development of investigator-initiated trials and all subsequent amendments in conjunction with Principal Investigators, study teams, review committees, and regulatory organizations.
  • Ensure compliance with federal, state, and institutional regulations, including FDA and OHRP guidelines.
  • Coordinate clinical study protocol development activities, including obtaining cross-functional input, ensuring incorporation of institution-specific requirements, and incorporating review comments.
  • Communicate with industry collaborators regarding protocol development, including obtaining letters of cross-reference and maintaining version control.
  • Work with internal committees, such as the Data Safety and Monitoring Board, and interact with biostatisticians to ensure alignment between the objectives stated in the investigational plan and the planned statistical analyses.
  • Create informed consent documents and other study materials.
  • Develop, track, and submit IND/IDE submissions, including initial applications, amendments, and annual reports to the FDA.
  • Ensure that institutional trials are registered and updated in ClinicalTrials.gov.
  • Manage the protocol development and IIT study activation timelines.
  • Serve as a functional area subject matter expert for protocol writing, FDA submissions, and regulatory reporting.
Requirements:
  • Bachelor's Degree in biological sciences, public health, or research-focused discipline.
  • Master's degree preferred.
  • Three years of experience in clinical research, including clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management.
  • Minimum two years of experience preparing submissions for the Institutional Review Board and/or scientific review committees.
  • Experience in protocol development and/or FDA IND/IDE submission is desirable but not required.
  • Knowledge of FDA and OHRP regulations, as well as International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines.
  • Thorough knowledge and experience with quantitative and qualitative research design, scientific research concepts, and terminology.
  • Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes, NIH RAC submission process, and submissions to other research review committees and regulatory bodies.
Preferred Qualifications:
  • Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC), or Association of Clinical Research Professional (ACRP) Certification.
Working Conditions/Physical Demands:

Standard office work.

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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