Senior Clinical Research Coordinator - Translational Trials

Vanderbilt Health; Nashville (TN); On-site; USD 60,000 - 75,000; Full time

Job summary

Vanderbilt Health in Nashville seeks a Clinical Translational Research Coordinator II to manage regulatory documents, screen and enroll participants, and ensure compliance across multiple studies. You will oversee data integrity, sponsor communications, and ethics adherence in a collaborative academic clinical research environment.

As part of the GI Medicine Clinical Trials group, you will coordinate start-up activities, manage study resources, and support audits and regulatory inspections while

Qualifications

• Experience in coordinating clinical trials and regulatory requirements.
• Familiarity with IRB submissions, GCP and human subject protection.
• Strong data management, QA practices, and documentation discipline.
• Effective cross-functional communication and teamwork.

Responsibilities

• Preparing, submitting, and managing regulatory documents, including IRB adverse event reports, and study-related correspondence.
• Maintaining essential regulatory, sponsor, and study documentation to ensure audit readiness.
• Coordinating study operations and procuring equipment, supplies, and resources for trials.
• Screening, recruiting, consenting, and enrolling participants per protocol.
• Evaluating medical records to confirm eligibility and ongoing compliance.
• Managing data in paper/electronic case report forms and resolving queries.
• Supporting sponsor monitoring visits, audits, and inspections with source documentation.
• Processing, packaging, and shipping biological specimens per protocol.
• Assisting with payment tracking and trial billing compliance.
• Facilitating informed consent and ensuring participant understanding.
• Advocating for participant safety and ethical conduct.
• Participating in research committees to improve processes.

Skills

Clinical Trial Management

Regulatory Affairs & IRB Submissions

Good Clinical Practice (GCP)

Human Subjects Protection

Participant Recruitment & Retention

Informed Consent Administration

Data Management & Quality Assurance

Sponsor and Regulatory Audits

Budget & Financial Oversight

Specimen Collection & Shipping

Site Management

Cross-Functional Communication

Project Coordination & Problem Solving

Education

Bachelor's degree

Tools

Clinical Research (Novice)

Study Design & Conduct (Novice)

Project Coordination (Novice)

Communication (Novice)

Job description

Vanderbilt Health in Nashville seeks a Clinical Translational Research Coordinator II to manage regulatory documents, screen and enroll participants, and ensure compliance across multiple studies. You will oversee data integrity, sponsor communications, and ethics adherence in a collaborative academic clinical research environment.

As part of the GI Medicine Clinical Trials group, you will coordinate start-up activities, manage study resources, and support audits and regulatory inspections while