Clinical Trials Regulatory Specialist

Socket.dev; New York (NY); On-site; USD 59,000 - 66,000; Full time

Job summary

Cornell University on the Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance for clinical trials from submission through closeout. You will coordinate submissions to IRB/CSEC, ensure subject enrollment complies with regulations, and maintain accurate regulatory records in a fast-paced healthcare setting.

The role requires a Bachelor's degree with ~2 years' clinical research experience; CCRP is preferred.

Qualifications

• Bachelor's degree in a related field required.
• Approximately 2 years of clinical research experience.
• CCRP certification preferred.
• Strong regulatory and documentation skills.

Responsibilities

• Coordinate protocol submission for research projects and prepare regulatory documents for IRB and CSEC.
• Facilitate enrollment of research subjects in compliance with regulations.
• Review eligibility and submit exceptions to IRB.
• Perform central subject registration for studies.
• Report SAEs to IRB and agencies as required.
• Prepare and submit regulatory documents to sponsor and/or CRO.
• Maintain regulatory records and ensure deadlines.
• Train junior staff on registration and regulatory processes.
• Maintain study listings and disseminate information to investigators.
• Coordinate site visits and audits of clinical trials.
• Attend conferences and disseminate information to staff.
• Maintain electronic and hard copy files.

Skills

Regulatory knowledge

Communication skills

MS Office Suite

Attention to detail

Multi-tasking

Professionalism

Team collaboration

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Database applications

Job description

Cornell University on the Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance for clinical trials from submission through closeout. You will coordinate submissions to IRB/CSEC, ensure subject enrollment complies with regulations, and maintain accurate regulatory records in a fast-paced healthcare setting.

The role requires a Bachelor's degree with ~2 years' clinical research experience; CCRP is preferred.