Clinical Trials Coordinator II: Regulatory, Data & Recruitment

Montgomery College; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Vanderbilt Health in Nashville is seeking a Clinical Translational Research Coordinator II to oversee coordination and management of clinical studies. You will ensure compliance with GCP, regulatory requirements, and human subject protections, while supporting data integrity across multi-study trials.

The role emphasizes regulatory documentation, participant recruitment, and cross-functional communication with investigators, sponsors, and research staff.

Qualifications

• Bachelor's degree in a related field.
• Experience in coordinating clinical and translational research studies.

Responsibilities

• Prepare, submit, and manage regulatory documents including IRB reports.
• Maintain essential regulatory and study documentation for audits.
• Coordinate study operations and procurement of equipment and resources.
• Screen, recruit, consent, and enroll participants per protocol criteria.
• Evaluate medical records to confirm eligibility and compliance.
• Manage clinical research data and resolve data queries.
• Support sponsor monitoring visits, audits, and inspections.
• Process, package, and ship biological specimens per protocol.
• Assist with trial billing compliance and payments.
• Facilitate informed consent and ensure participant understanding.

Skills

GCP

IRB Submissions

Regulatory Affairs

Data Management

Study Start-Up

Project Coordination

Budget Oversight

Audits & Compliance

Education

Bachelor's

Job description

Vanderbilt Health in Nashville is seeking a Clinical Translational Research Coordinator II to oversee coordination and management of clinical studies. You will ensure compliance with GCP, regulatory requirements, and human subject protections, while supporting data integrity across multi-study trials.

The role emphasizes regulatory documentation, participant recruitment, and cross-functional communication with investigators, sponsors, and research staff.