Clinical/Translational Research Coordinator II – Onsite, Nashville TN at Vanderbilt Health

Job description

Discover Vanderbilt Health : With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region. Organization: GI Medicine Clinical Trials Job Summary: This position will support the GI Clinical Research Enterprise (GICRE) and is responsible for the independent management and oversight of complex clinical research protocols. The Clinical Translational Research Coordinator II will serve as a subject matter expert and lead the coordination of all aspects of clinical trial conduct, including patient recruitment and retention, informed consent, study visits, specimen collection and processing, data management, regulatory compliance, and sponsor interactions. This role collaborates closely with principal investigators, study participants, sponsors, vendors, and multidisciplinary clinical teams to ensure protocol adherence, data integrity, and compliance with institutional, regulatory, and sponsor requirements. The CTRC II exercises a high degree of autonomy in managing study operations, troubleshooting protocol-related issues, and supporting the successful execution of clinical research activities. This position serves as the primary coordinator for the GI Clinical Research Dr Ashley Spann’s PCORI grant. Under the delegation of the Principal Investigator, the Clinical Translational Research Coordinator II is responsible for the receipt, accountability, safe handling, storage, dispensing, reconciliation, and return or destruction of investigational products utilized in clinical trials. The incumbent ensures compliance with sponsor requirements, Good Clinical Practice (GCP), FDA regulations, institutional policies, and study-specific protocols. . Preferred Skills and Experience: Clinical research experience in an academic medical center, hospital, research institute, or healthcare setting Experience with patient recruitment, screening, and participant enrollment Strong data entry skills with a high degree of accuracy and attention to detail Experience interacting directly with patients and providing patient care or patient-facing support Electronic Medical Record (EMR/EHR) systems (such as Epic) Knowledge of clinical research processes, study protocols, informed consent, and regulatory requirements Microsoft Office Suite, especially Excel, Outlook, and Teams Ability to manage multiple studies, priorities, and deadlines simultaneously Strong written and verbal communication skills for participant, sponsor, and investigator interactions Experience resolving data queries and maintaining data quality Electronic Data Capture (EDC) systems REDCap experience Clinical Trial Management Systems (CTMS) experience KEY RESPONSIBILITIES Clinical research project coordination: Participate in determination of patient eligibility, engages in the ongoing consent process, coordinates patient visit as per protocol, conducts patient visit, and scheduling of test/procedures. CTRC II will liaison between PI and sponsor to ensure proper execution of clinical trial. Collect and process laboratory samples for shipment to sponsor central lab. Investigational product management: Specific Examples: The CTRC II is responsible for the daily management of investigational product. The tasks include, but not limited to, daily storage temperature monitoring, investigational product (IP) receipt, storage, dispensation, IP accountability, labeling, and return of IP Documentation / Data Entry: S