IRB & Regulatory Lead – Clinical Trials

Socket.dev; Nashville (TN); On-site; USD 70,000 - 100,000; Full time

Job summary

Vanderbilt Health is seeking a Research Regulatory Analyst to liaise with the IRB and coordinate regulatory components of research protocols from start-up to close-out. You will ensure integrity and quality of clinical/translational research in accordance with regulatory policies.

The role requires experience with IRB submissions, regulatory compliance, and multi-site coordination, with strong attention to detail and project management. Oncology research experience is highly valued.

Qualifications

• Experience coordinating clinical research trials with documentation.
• Proficiency in IRB submissions and regulatory processes.
• Experience obtaining informed consent from participants.
• Knowledge of FDA/OHRP/GCP/ICH and HIPAA guidelines.
• Oncology clinical research experience preferred.

Responsibilities

• Independently collects and maintains regulatory documents for trials.
• Prepares IRB proposals, amendments, continuing reviews, and adverse event reports.
• Performs QC audits of regulatory documents using OnCore and Veeva.
• Develops proactive solutions to regulatory issues and maintains timelines.
• Collaborates with monitors, auditors, and sponsors to ensure compliance.

Skills

Clinical research coordination

Informed consent

IRB compliance

Attention to detail

Multi-tasking

Regulatory familiarity

Oncology research

Education

Bachelor's degree

Tools

OnCore

Veeva

Microsoft Excel

REDCap

Job description

Vanderbilt Health is seeking a Research Regulatory Analyst to liaise with the IRB and coordinate regulatory components of research protocols from start-up to close-out. You will ensure integrity and quality of clinical/translational research in accordance with regulatory policies.

The role requires experience with IRB submissions, regulatory compliance, and multi-site coordination, with strong attention to detail and project management. Oncology research experience is highly valued.