Clinical Translational Research Coordinator III (Idrees)

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Clinical Translational Research Coordinator III in the Kamran Idrees Lab independently coordinates and manages the start-up, conduct, and closeout of clinical and translational research studies focused on histotripsy, a noninvasive focused ultrasound technology. The coordinator helps ensure scientific integrity, participant safety, and compliance with institutional policies, Good Clinical Practice (GCP), and sponsor and regulatory requirements. The role leads day-to-day study operations, including regulatory documentation and audit readiness, data collection and query resolution, clinical biorepository and specimen lifecycle management, study budgets and invoicing oversight, and process improvement guided by performance metrics. The coordinator serves as a primary liaison among investigators, sponsors, research staff, and participants. The position is within Vanderbilt’s Division of Surgical Oncology and Endocrine Surgery, which provides multidisciplinary care for patients with benign and malignant tissue disorders. The role may also involve coordinating research across multiple sites and supporting participant recruitment, study visits, assessments, specimen handling, data quality, billing compliance, reporting, and study archiving. Additional duties may be assigned.

Requirements

Bachelor’s degree or equivalent experience.
Three years of relevant work experience.
Ability to coordinate clinical research activities and manage study documentation, data, and protocol procedures.
Knowledge of Good Clinical Practice, institutional policies, and sponsor and regulatory requirements, as applicable to the role.

Nice To Haves

Biorepository experience.

Responsibilities

Manage a clinical biorepository, including obtaining patient consent, tracking follow-up visits, processing fresh specimens, maintaining specimen inventory and storage, and updating biorepository, study, and registry databases.
Prepare and maintain accurate, compliant study documents for internal use and review by regulatory authorities or sponsors before, during, and after trials.
Participate in sponsor and regulatory site visits and data quality assurance reviews.
Coordinate research protocols, including participant recruitment, screening, scheduling, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking, and other protocol-specific procedures.
Identify and procure equipment and supplies required for projects, including across multiple sites when needed.
Record source data and participant information on paper or electronic case report forms, ensuring accuracy, completeness, and timeliness; maintain compliant research records and resolve data queries promptly.
Participate in developing data collection tools.
Receive and track study specimens from multiple sites; package and ship specimens according to sponsor, laboratory, and regulatory requirements, maintaining appropriate documentation.
Manage study completion processes, including data lock, closeout, reporting, and archiving; check entered clinical and translational data and ensure study documentation is complete and continuous.
Develop and manage study budgets with department administration, monitor invoicing, support clinical trial billing compliance, and provide reports to investigators, administrators, and funding agencies.
Advocate for human research participants through communication with investigators, research staff, sponsors, participants, and other relevant representatives, and through ongoing monitoring of trial processes and participants.
With guidance, assess and evaluate potential participants’ relevant medical and historical information.
Identify and implement process improvements to support research quality, recruitment, timely payments, cost savings, and efficient study reporting.
Define and use performance metrics, share them with investigators and administrators, and track the effectiveness of improvement efforts.
Coordinate study centers and ensure sites have trial materials and staff training appropriate to trial-specific industry standards.
Track and report project tasks, dependencies, schedules, and issues; manage prioritization and change-control procedures and follow work through to completion.