Clinical Translational Research Coordinator III (Idrees)

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: 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 study reporting Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes The responsibilities listed are a general overview of the position and additional duties may be assigned. TECHNICAL CAPABILITIES • Clinical Research (Intermediate): Demonstrates the ability to effectively research complicated issues pertaining to the area of expertise. Presents trial protocols to a steering committee. Often employs networking to help in researching issues. Sets up study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards. Has used research resources maintained in outside areas. • People Management (Novice): Conducts performance reviews. Effectively delegates tasks to others. Coaches subordinates on technical and interpersonal topics, as well as professional development. Demonstrates team building techniques and provides leadership through personal example of good work habits, open communication and effective people relationships. Involves subordinates in decisions which affect them. Demonstrates self-reliance and resourcefulness as an example to others. • Study Design & Conduct (Intermediate): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study. • Project Coordination (Intermediate): Performs project tracking and reporting relative to task completion dates, dependency effects, problem anticipation, schedule conflicts, and assignment to appropriate staff for resolution. Manages prioritization procedures for changing scope [i.e., change management] and project acceptance procedures. Measures progress toward goals and revises project objectives and documents applying change control procedures. Assumes responsibility [as appropriate] for resolving issues and seeing work through to successful completion. Provides training to project managers and others on project related templates