Vanderbilt University Medical Center Clinical Research Associate 2 in Nashville, Tennessee
Clinical Research Assoc II (Vanderbilt Ingram Cancer Center)
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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.
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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/
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, and other duties as assigned assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.
Remote and On-Site Monitoring Responsibilities and Assessment of Site Performance
Ensure study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure timely distribution of monitoring visit reports and any supplemental documents/reports to all sites as part of our contribution to the expeditious completion of the study procedures and data collection as well as building and maintaining relationships between sites and the Coordinating Center
Ensure the resources of the funder and Vanderbilt University Medical Center are spent wisely by performing the required monitoring tasks in an efficient manner according to established SOPs and guidelines
When traveling will adhere to all applicable policies and guidelines of Vanderbilt University Medical Center including managing travel expenses in an economical fashion and preparing accurate and timely trip reports
Perform Case Report Form Review
Review case report form, query generation and resolution against established monitoring plan guidelines, with or without direct supervision, on Vanderbilt University Medical Center data management systems
Assist with Administration of Clinical Research Projects
Assist in recruitment/review of investigators, collecting investigator documentation and site management
Update, track and maintain study-specific trial management tools/systems
Generate and track drug shipments and supplies as needed
Attend investigator meetings, project team meetings and teleconferences as needed
Coordinate slot allocation/randomization of study patients across all sites, providing timely study updates as needed to all applicable site personnel.
Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties.
Assist with site/study audit preparation and follow up on Corrective Action Plan responses as needed
Provide Coverage for Clinical Contact
Assist CRAIII in clinical coverage via telephone, email, or in-person as required
Perform other duties as assigned by management
In addition to offering a lively community that encourages learning and celebrates diversity, Vanderbilt University Medical Center provides its faculty and staff members with a benefits package that is comprehensive and flexible. Components for benefits-eligible employees include:
Accidental Death & Dismemberment (AD&D)
Flexible Spending Accounts (FSAs)
Minimum Qualifications Required
- Bachelor's Degree (or equivalent experience) and 2 years experience
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 at http://www.vanderbilthealth.com/billwilkerson/ ), 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 Tennessee
· Nashville Business Journal: Middle Tennessee's healthiest employer
· American Hospital Association: among the 100 "Most Wired" medical systems in the US
*Additional Qualification Information*
- Prior to advancing to a Clinical Research Associate II, must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.
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: VICC- Clinical Trials 60 104266
Title: Clinical Research Associate 2
Location: TN-Nashville-3322 West End Avenue
Requisition ID: 1809928
Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.