Clinical Trials Regulatory Specialist

Weill Cornell Medicine; New York (NY); On-site; USD 60,000 - 67,000; Full time

Job summary

Weill Cornell Medicine in New York’s Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance from study submission through closeout. You will coordinate protocol submissions, ensure regulatory compliance, and support subject enrollment under clinical trial guidelines.

The role requires a Bachelor's degree, ~2 years in clinical research, and strong MS Office/database skills. A Master’s degree may substitute for experience; non-exempt, 35 weekly hours.

Qualifications

• Bachelor's Degree in 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.

Responsibilities

• Coordinates protocol submissions for research projects and submits documents to CSEC, IRB and committees.
• Facilitates subject enrollment in compliance with regulations and guidelines.
• Reviews subject eligibility and regulatory compliance for enrollment; submits eligibility exceptions to IRB.
• Performs central subject registration for specified studies.
• Reports Serious Adverse Events (SAEs) to IRB and other agencies as required.
• Prepares and submits regulatory documents to sponsor or CRO.
• Maintains up-to-date regulatory records and deadlines.

Skills

Communication skills

MS Office

Organizational skills

Critical thinking

Multitasking

Discretion

Professionalism

Collaboration

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Database applications

Job description

Weill Cornell Medicine in New York’s Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance from study submission through closeout. You will coordinate protocol submissions, ensure regulatory compliance, and support subject enrollment under clinical trial guidelines.

The role requires a Bachelor's degree, ~2 years in clinical research, and strong MS Office/database skills. A Master’s degree may substitute for experience; non-exempt, 35 weekly hours.