Clinical Translational Reseach Coordinator III (Idrees)

About this role

Discover Vanderbilt University Medical Center :  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization: Surgical Oncology & Endocrine Surgery Job Summary: In your pivotal role as Clinical/Translational Research Coordinator III in the Kamran Idrees Lab, you will independently coordinate and manage the start-up, conduct, and closeout of clinical/translational research studies focused on histotripsy—an innovative, noninvasive focused ultrasound technology that mechanically destroys targeted tissue without surgery, radiation, or heat-based ablation. You will help ensure scientific integrity, participant safety, and full compliance with institutional policies, Good Clinical Practice (GCP), and sponsor/regulatory requirements. You will lead day-to-day study operations such as regulatory documentation and audit readiness; accurate and timely data collection with query resolution; clinical biorepository and specimen lifecycle management (processing, inventory, multi-site tracking, and compliant shipping); study budgets and invoicing oversight; and continuous process improvement driven by defined performance metrics—serving as a primary liaison among investigators, sponsors, research staff, and participants.

REQUIRED: • Bachelor’s (or equivalent experience) • 3 years of experience • Biorepository experience is a plus . DEPARTMENT SUMMARY : The Vanderbilt Division of Surgical Oncology and Endocrine Surgery, a part of the Vanderbilt Department of Surgery, has quickly become a national leader in comprehensive surgical care. Our emphasis is placed on the evaluation and treatment of patients with benign and malignant tissue disorders. We use a multidisciplinary approach to patient care and work closely to coordinate our efforts with the Divisions of Radiation Oncology, Medical Oncology, Gynecologic Oncology, Hematology, Surgical Pathology, Radiology and other disciplines.  For more information, please visit https://www.vumc.org/surgical-oncology/welcome .

KEY RESPONSIBILITIES • Responsibilities for management of a clinical biorepository, including obtaining patient consent, tracking patient follow-up visits, processing fresh specimens, maintaining specimen inventory and storage, and updating biorepository, study, and registry databases. • Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews. • Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures • Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required) • Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools • Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation • Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation • With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies • Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants. With guidance, assesses and evaluates potential participants pertinent medical and historical information. • Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient st

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