Clinical Research Coordinator - Translational Trials

Vanderbilt University Medical Center; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

Vanderbilt University Medical Center is seeking a Clinical Translational Research Coordinator II for the GI Medicine Clinical Trials program in Nashville. You will coordinate regulatory processes, manage study documentation, and support operations across multiple trials with a focus on patient safety and data integrity.

Responsibilities include IRB submissions, subject recruitment, consent, data management, and audits while collaborating with sponsors and investigators to advance translational

Qualifications

• Bachelor's degree in a related field is required.
• Minimum 1 year of relevant work experience in clinical research.
• Strong knowledge of regulatory requirements and GCP.
• Ability to coordinate complex studies across teams.

Responsibilities

• Prepare, submit, and manage regulatory documents including IRB reports and study correspondence.
• Maintain essential regulatory, sponsor, and study documentation for audits and inspections.
• Coordinate study operations including equipment, supplies, and resources for multi-study trials.
• Screen, recruit, consent, and enroll participants per protocol criteria.
• Evaluate medical records to confirm eligibility and ongoing compliance.
• Manage clinical data entry, data queries, and data integrity.
• Support sponsor monitoring visits, audits, and regulatory inspections with source docs.
• Process, package, and ship biological specimens per protocol and shipping rules.
• Assist with payment tracking and trial billing compliance.
• Facilitate informed consent processes and ensure participant understanding.
• Advocate for participants and promote ethics, safety, and regulatory compliance.
• Participate in research committees and institutional initiatives for process improvement.

Skills

Clinical trial management

Regulatory affairs

IRB submissions

GCP

Human subjects protection

Recruitment & retention

Informed consent administration

Data management & QA

Audits & sponsor monitoring

Budget & financial oversight

Study start-up & site management

Cross-functional communication

Regulatory compliance

Education

Bachelor's degree in a relevant field

Job description

Vanderbilt University Medical Center is seeking a Clinical Translational Research Coordinator II for the GI Medicine Clinical Trials program in Nashville. You will coordinate regulatory processes, manage study documentation, and support operations across multiple trials with a focus on patient safety and data integrity.

Responsibilities include IRB submissions, subject recruitment, consent, data management, and audits while collaborating with sponsors and investigators to advance translational