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Clinical Research Data Specialist (VICC)1911718Your Role:· JOB SUMMARY:This position is responsible for the data management functions and conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.KEY RESPONSIBILITIES:
Data Management
Inputs, reviews and submits eligibility documentation into data capture systems for a portfolio of studies. Identifies and resolves any documentation discrepancies.
Correctly and efficiently abstracts information from the EMR for multiple studies. Able to manage additional assignments as needed for fast accruing studies.
Identifies AEs from EMR, provides support to correctly and completely record AEs and serves as resource to CTA II staff. Assists with trending reports on AEs for each trial and across teams.
Submits to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials. Acts as preceptor for CTA II staff.
Reviews and approves responses to sponsor queries from CTA IIs. Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification on ongoing issue
External Sponsor Monitoring and Visit Management
Coordinates monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations.
Meets with monitors to review data monitoring results, answer questions and resolve queries. Demonstrates effective communication with external monitors. Mentors data team on resolving issues.
Quality Assurance/Internal Monitoring
Queries research team to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Mentors and trains CTA II staff to communicate effectively with the research team as needed.
Identifies and resolves discrepancies with research team. Mentors and assists data team in effective discrepancy resolution as needed.
Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
Trains CTA II staff in good clinical and research practices as it relates to data management as needed. Encourages input as it relates to process improvement.
Prepares for and participates in clinical trial audits. Mentors and trains CTA II staff to prepare for and participate in internal and external audits as needed.
Position Qualifications:Required:· Bachelors (or equivalent experience) and 3 years of experience.Position Shift:· Day Shift/Exempt PositionDepartment/Unit Summary:· Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 49 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.org/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 DiscoveryVUMC Recent AccomplishmentsBecause 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 at http://www.vanderbilthealth.com/billwilkerson/ ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training· Truven Health Analytics: among the top 100 hospitals in the US· 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· American Association for the Advancement of Science: 12 faculty members elected fellows in 2014· 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 USCAIND000NHCNPhysical Requirements/Strengths needed & Physical Demands:Movement
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.
Sensory
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.
Environmental ConditionsJob ResearchOrganization: VICC- Clinical Trials 160 104311Title: Clinical Research Data SpecialistLocation: TN-Nashville-3322 West End AvenueRequisition ID: 1911718Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.
