Clinical Trials Regulatory Strategist

NYU Langone Health; New York (NY); On-site; USD 66,000 - 81,000; Full time

Benefits offered by this job

Comprehensive benefits

Wellness program

Job summary

NYU Langone Health seeks a Research Regulatory Specialist to support initiation and activation of clinical trials within the Division of Endocrinology. You will act as the internal regulatory expert, coordinating submissions and providing regulatory guidance to study teams and sponsors.

Reporting to the Research Program Manager, you will liaison with sponsor, CRO, IRB, FDA and internal departments to ensure timely activation and compliance with GCP guidelines and sponsor specifications.

Qualifications

• Bachelor's degree and at least 2 years of research experience with regulatory compliance knowledge.
• Excellent communication, analytical, presentation and time management skills.
• Preferred: Master's degree in Public Health or health-related field.

Responsibilities

• Initiate contracts and budgets for clinical trials and ensure timely activation.
• Communicate with local and national regulatory authorities.
• Complete site qualification questionnaires and assess division readiness.
• Create regulatory master files for industry and investigator-initiated trials.
• Develop trial-specific informed consent forms and local protocols.

Skills

Regulatory compliance

Communication

Analytical thinking

Time management

Education

Bachelor's degree

Master's degree (preferred)

Tools

MS Office

Databases & spreadsheets

GCP knowledge

Job description

NYU Langone Health seeks a Research Regulatory Specialist to support initiation and activation of clinical trials within the Division of Endocrinology. You will act as the internal regulatory expert, coordinating submissions and providing regulatory guidance to study teams and sponsors.

Reporting to the Research Program Manager, you will liaison with sponsor, CRO, IRB, FDA and internal departments to ensure timely activation and compliance with GCP guidelines and sponsor specifications.