Clinical Translational Research Coordinator II, GI Medicine - Onsite, Nashville TN

Vanderbilt University Medical Center•Nashville, TN

2d•Onsite

About The Position

The Clinical Translational Research Coordinator II coordinates and manages clinical and translational research studies, ensuring compliance with institutional policies, federal regulations, Good Clinical Practice (GCP), and human-subject protection requirements. The role supports study operations across the clinical trial lifecycle, including regulatory submissions and documentation, participant recruitment and consent, data management, specimen handling, monitoring visits, billing compliance, and communication among research stakeholders. The position also promotes participant safety and ethical research conduct and participates in committees and institutional initiatives aimed at continuous improvement of clinical research practices.

Requirements

Bachelor’s degree.
One year of relevant work experience.
Knowledge of clinical trial management, regulatory affairs and IRB submissions, GCP, human-subject protection, participant recruitment and retention, informed consent, data management and quality assurance, audits, budget and financial oversight, specimen collection and shipping, study start-up and site management, cross-functional communication, research compliance, and project coordination.
Ability to review project documents for completeness and accuracy, track project status and work requests, maintain records, and provide administrative and logistics support.
Ability to communicate clearly, effectively, and respectfully with employees or customers.

Responsibilities

Prepare, submit, and manage regulatory documents, including IRB adverse event reports and study-related correspondence.
Maintain essential regulatory, sponsor, and study documentation to support audit and inspection readiness throughout clinical trials.
Coordinate study operations by procuring equipment, supplies, and resources for multiple studies.
Screen, recruit, consent, and enroll participants in accordance with protocol-specific inclusion and exclusion criteria.
Review medical records and participant histories to confirm eligibility and ongoing compliance with study requirements.
Enter research data into paper and electronic case report forms, resolve data queries, and support data integrity and regulatory compliance.
Support sponsor monitoring visits, audits, and regulatory inspections by maintaining source documentation, study records, and research procedures.
Process, package, and ship biological specimens according to protocol requirements, laboratory standards, and applicable shipping regulations.
Assist with payment tracking and clinical trial billing compliance.
Facilitate informed consent and ensure participants and their families understand study requirements, risks, and expectations.
Advocate for research participants by promoting ethical conduct, participant safety, regulatory compliance, and effective communication among investigators, sponsors, research staff, and participants.
Participate in research-related committees and institutional initiatives to promote continuous process improvement and clinical research best practices.
Provide administrative and logistics support for project meetings, training, workshops, and facilitated sessions.
Coordinate and track work requests, maintain project plans and records, and help ensure project milestones and deliverables are met.