Primary Location: TN-Nashville-2525 West End Ave
Organization: VICTR Vanderbilt Coord Center 104241
Clinical Research Projects Coordinator – VICTR – VCC
This is a full-time/non-exempt term position lasting six months to one year.
In your pivotal role as a Clinical Research Projects Coordinator, you will assist in Project Tracking and Navigation by supporting Clinical Research Navigators and serving as a liaison to central resource offices. You will also provide clinical trials assistance by assisting with scheduling visits and providing appropriate access to external vendors and monitors. As a Clinical Research Projects Coordinator, you will also provide general administrative support.
• Support Clinical Research Navigators in ensuring proper and efficient study startup
• Help identify opportunities for improving study startup processes and timelines and assist with constructing and evaluating potential solutions
• Serve as a liaison to central research offices within VUMC in order activate new studies, ensure regulatory compliance for ongoing studies, and communicate and receive approval for study amendments
• Tracks, trends, and reports project specific performance metrics to leadership using available methodologies and tools; establish, maintain, and suggest improvements to tracking tools for assigned trials
• Collates individual project metrics into an overall integrated department report
• Follow-up on all content inputs from subject matter experts & internal teams to ensure projects remain on track
• Assess risks in the event of delay in receiving inputs; responsible for communicating and escalating potential risks to the direct supervisor
• Assists team members in ensuring GCP compliance through ICH assignment, tracking, and reporting
Clinical Trial Assistance
• Participate in sponsor and internal study-related meetings when applicable
• Assist with scheduling visits and providing appropriate access to external vendors and monitors
• Support local study recruitment and enrollment reporting
• Support maintenance of the overall structure of electronic Trial Master Files (eTMF’s) and assist with quality control as appropriate
• Receive study documents, review for completion, and accuracy and submit to the eTMF; audit existing data in eTMF for expiring and missing documents, signatures, and completeness
• Examine subject files, extract research-related patient data from the Electronic Health Record and log study metrics in study-related databases and Case Report Forms
• Assist with the maintenance and filing of all forms of regulatory documents including consent forms, master subject logs, Key Study Personnel lists, licenses and CV’s and appropriate correspondence
• Assist in the maintenance of operational study materials including but not limited to presentations, protocols, status reports, project management plans, Gantt Charts, operating guidelines, internal policies and procedures, manuscripts, and posters
• Send requests for medical records release, receive documents and review for study-related data
• Distribute clinical trial related materials to sites, clinical staff, and/or study team members
• Prepare, process, and ship specimens/samples accurately under well-defined requirements
• Assist with the management of study supplies and organize shipments as needed
General Administrative Support
• May support a variety of areas, projects and programs within the VCC’s Local Support Services, Program for Investigator Initiated Trials, and Central Operations
- Assist with tracking predefined invoice-able contract milestones and Core billable time
- Provide updates to staff regarding Core billable time in an effort to stay on track with projected hours
• Triage and/or answer questions received from the Vanderbilt Coordinating Center’s general telephone line
• Manage conference rooms and team-related Outlook calendars
• Participate in internal meetings and assist in preparation of agendas, minutes, and tracking of action items
• Responsible for routine departmental support including maintaining supplies, shipping, archiving, filing, faxing and scheduling meetings
• Coordinate event logistics for program meetings, activities, seminars, and briefings
• Draft and edit policies, guidance documents, and other reference material as appropriate
• Assists with program outreach activities and contacts management
• Update web and social media content to reflect project developments
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt’s virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center’s Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/.
Click Here To View The VUMC Promise of Discovery
Click here to view how Vanderbilt Health employees celebrate the difference they make every day:
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. It is a place 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.
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments.
- US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
- Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
- Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
- The Leapfrog Group: grade "A" in Hospital Safety Score
- National Institutes of Health: among the top 10 grant awardees for medical research in the US
- Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
- Nashville Business Journal: Middle Tennessee's healthiest employer
- American Hospital Association: among the 100 "Most Wired" medical systems in the US
This is a term position. A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends. This position may also have the opportunity to work remotely.
- Bachelor's Degree (or equivalent experience)
- <1 year of experience
Highly Desirable Qualifications
• Clinical trial or other general databases (such as REDCap, a Clinical Trial Management System (CTMS) or Microsoft Access)
- Physical Requirements/Strengths needed & Physical Demands:
- Occasional: Sitting: Remaining in seated position
- Occasional: Standing: Remaining on one's feet without moving.
- Occasional: Walking: Moving about on foot.
- Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
- Occasional: Push/Pull: Exerting force to move objects away from or toward.
- Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
- Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
- Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
- Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
- Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
- Continuous: Communication: Expressing or exchanging written/verbal/electronic information.