Title: Regulatory & Protocol Development Specialist
Title: Regulatory & Protocol Development Specialist
Location: Midtown
Org Unit: Regulatory
Work Days: Monday-Friday
Weekly Hours: 35.00
Exemption Status: Exempt
Salary Range: $81,800.00 - $92,900.00
*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary
Under general direction, and in compliance with Weill Cornell Medicine (WCM) and Meyer Cancer Center (MCC) policies, and federal and state regulations, works closely with investigators, their study teams, regulatory personnel, and external collaborators to manage the development of investigator-initiated clinical trials.
Job Responsibilities
- Manages the development of investigator-initiated trials and all subsequent amendments in conjunction with Principal Investigator (PI), study team, review committees and regulatory organizations to support MCC initiatives.
- Ensures compliance with Federal, State, WCM, external collaborators and MCC standards and policies.
- Coordinates clinical study protocol development activities; obtains crossfunctional input, ensures incorporation of institution specific requirements to protocol; incorporates review comments, and assists in finalizing complete clinical study protocol.
- Communicates with industry collaborators regarding protocol development (i.e., obtains letter of cross reference, maintains version control edits, and incorporates sponsor-specific safety reporting).
- Works with internal committees such as the Data Safety and Monitoring Board (DSMB) and interacts with biostatisticians to ensure alignment between the objectives stated in the investigational plan and the planned statistical analyses.
- Creates informed consent documents and other study materials.
- Develops, tracks and submits IND/IDE submissions including initial applications, amendments and annual reports to the FDA.
- Ensures that institutional trials are registered and updated in ClinicalTrials.gov.
- Manages the protocol development and the IIT study activation timelines.
- Serves as a functional area subject matter expert for protocol writing, FDA submissions, and regulatory reporting.
- Performs other related duties as assigned or requested.
Education
- Bachelor's Degree
Experience
Bachelor’s Degree in biological sciences, public health, or research focused discipline.
Master’s degree preferred.
Three years of experience in clinical research to include, but not limited to 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 the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
Knowledge of 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 submitted to other research review committees and regulatory bodies.
Knowledge, Skills and Abilities
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated critical thinking and analytical skills.
- Demonstrated proficiency with MS Office Suite and database applications.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to remain focused despite frequent interruptions.
- Ability to treat confidential information with utmost discretion.
- Demonstrated ability to function independently and exercise independent judgment.
- Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
- Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
Licenses and Certifications
- Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC), or, Association of Clinical Research Professional (ACRP) Certification preferred.
Working Conditions/Physical Demands
Standard office work.
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 in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. 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.
Nearest Major Market: Manhattan
Nearest Secondary Market: New York City