Clinical Translational Research Coordinator III - Hybrid/Onsite, Nashville TN

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 diverse 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 recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading 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:

VICC - Clinical Trials 40

Job Summary:

The Regulatory Coordinator III position with the Vanderbilt-Ingram Cancer Center (VICC) Clinical Trials Office (CTO) is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff.

• Demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA)
• Provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures as follows
• Serve as primary regulatory contact with the sponsoring agency for regulatory approvals
• Evaluate the protocol and sponsor documents and determine if additional items are needed for IRB/Sponsor approval
• Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and institutional requirements
• Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval
• Complete the IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly
• Manage essential documents in accordance with the sponsor, IRB and federal government requirements
• Submit amendment and continuing review data, investigate study irregularities and guide staff in reporting and documentation of events
• Submit studies for closure and resolve any outstanding relevant findings with the sponsor and/or study team
• Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB

.

KEY RESPONSIBILITIES
• 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 repor