Vanderbilt University Medical Center Clinical Research Projects Coordinator in Nashville, Tennessee
VICTR - Vanderbilt Coordinating Center (VCC)
• 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
Associate's Degree (or equivalent experience) and 2 years experience
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.
Organization: VICTR Vanderbilt Coord Center 104241
Title: Clinical Research Projects Coordinator
Location: TN-Nashville-Village at Vanderbilt
Requisition ID: 1805618
Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.