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

Vanderbilt University Medical Center•Nashville, TN

1d•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 clinical trial operations across multiple studies, from regulatory submissions and participant enrollment to data management, specimen handling, monitoring visits, and billing compliance. It also advocates for research participants, promotes ethical conduct and safety, communicates with investigators, sponsors, research staff, participants, and families, and contributes to research committees and process improvement initiatives. The position requires a bachelor's degree and at least one year of relevant work experience.

Requirements

Bachelor's degree.
At least 1 year of relevant work experience.
Knowledge of clinical trial management, regulatory affairs and IRB submissions, GCP, and human-subject protection.
Ability to recruit and retain participants and administer informed consent.
Skills in research data management and quality assurance.
Knowledge of sponsor and regulatory audits, budget and financial oversight, specimen collection and shipping, study start-up and site management, research compliance, project coordination, and problem solving.
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 ensure readiness for audits and inspections throughout clinical trials.
Coordinate study operations by procuring equipment, supplies, and resources needed to execute multiple studies.
Screen, recruit, consent, and enroll participants according to protocol-specific inclusion and exclusion criteria.
Review medical records and participant histories to confirm eligibility and ongoing compliance with study requirements.
Enter clinical research data into paper and electronic case report forms, resolve data queries, and ensure 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.
Participate in research-related committees and institutional initiatives to promote continuous process improvement and clinical research best practices.