Description Clinical Research Projects Coordinator VICTR – Vanderbilt Coordinating Center – VCC Requisition Number 1901061
Your Role : In your role as Clinical Research Projects Coordinator, you will support the activities of the Principal Investigator through project tracking and navigation, assistance with clinical trials, interacting with study participants, and general administrative support.
Required : - Associate's Degree (or equivalent experience)
- 2 years of relevant experience
Preferred :
Experience with Microsoft Excel Knowledge of medical terminology Project management with long-term projects Working with data, including preparation of quality graphs and tables Good professional writing and communication Good organizational and prioritizing capabilities Critical thinking abilities Highly Desirable Qualifications :
Good presentation and PowerPoint skills Experience working within an academic medical center Clinical trial or other general databases (such as REDCap, a Clinical Trial Management System (CTMS) or Microsoft Access) Expert in Microsoft Excel Previous clinical trial internship Project Tracking and Navigation : 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 Study Participant Interaction : Assist with structured community-based study screening and recruitment Schedule and/or call subjects for appointments; contact participants with reminders, location details, and any other requirements Perform telephone or in-person interviews to gather data as needed on active study participants Process study compensation payments and thank you letters to subjects Provide assistance to participants being seen within the Clinical Trials Center by welcoming them, ensure they are comfortable while they wait to be seen, and ensure that any questions they have related to their study visit are answered 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 Other duties as assigned Department Summary : The mission of the Vanderbilt Institute for Clinical and Translational Research (VICTR) , which is of strategic importance to our institution and its research operation, is to remove impediments to translational science so that innovations reach the people who need them more quickly. We are a workforce united not only by common purpose but also by common values. In collaboration with the VUMC Human Research Protections Program (HRPP), the Translational Research Navigator II assists with the optimal application of the Federal, State, and local laws, guidance documents, VUMC Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VUMC research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The TRN II researches topics of departmental, institutional or strategic importance.
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. 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. Click Here To View The VUMC Promise of Discovery VUMC Recent Accomplishments: 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 *CA |
