Clinical Regulatory Specialist

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

Job summary

Weill Cornell Medicine on the Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance for clinical trials from submission through closeout. The role coordinates IRB submissions, ensures compliance with deadlines, and trains staff.

The ideal candidate has a Bachelor's degree and about 2 years of clinical research experience; a Master's can substitute for experience. Proficiency with MS Office and database applications, plus strong communication and organizational skills,

Qualifications

• Bachelor's Degree in related field required.
• Approximately 2 years of clinical research experience preferred.
• Experience with regulatory submissions and regulatory compliance.

Responsibilities

• Coordinates all aspects of protocol submission for research projects and submits documents to IRB/CSEC.
• Facilitates enrollment of research subjects in compliance with regulations.
• Reviews subject eligibility and submits eligibility exceptions to the IRB.
• Performs central subject registration for specified studies.
• Reports Serious Adverse Events to IRB and other agencies as required.
• Prepares regulatory documents for sponsors/CROs and maintains records.
• Provides training to junior staff on subject registration and regulatory processes.
• Maintains listings of active and potential studies for investigators.
• Coordinates site visits and audits of clinical trials.
• Attends conferences and disseminates information to clinical staff.

Skills

Regulatory knowledge

Communication

MS Office

Organization

Attention to detail

Multi-tasking

Confidentiality

Professionalism

Collaboration

Education

Bachelor's Degree in related field

Job description

Weill Cornell Medicine on the Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance for clinical trials from submission through closeout. The role coordinates IRB submissions, ensures compliance with deadlines, and trains staff.

The ideal candidate has a Bachelor's degree and about 2 years of clinical research experience; a Master's can substitute for experience. Proficiency with MS Office and database applications, plus strong communication and organizational skills,