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 â of culture, thinking, learning and leading â 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. Vanderbiltâs mission is to advance health and wellness through preeminent programs in patient care, education, and research.
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/
JOB SUMMARY: Develop and coordinate mechanisms to assure compliance with human subject protection guidelines. Coordinate regulatory, data safety evaluation, and protocol development functions for on-site and multiple sites/affiliates. Provide oversight and education to staff involved in research studies. Audit investigator-initiated protocols and data and present findings to regulatory committees. Assist with study feasibility and budget development.
Act as liaison of research activities between investigators, agencies, sponsoring companies, regulatory committees and other participants.
Oversees the development of protocols, the overall clinical plan, draft protocols, and coordinates the protocol review and approval process with various committees and staff.
Supervise staff, monitor data, and assign corrective measures for adherence to protocol and regulatory compliance.
Perform ongoing monitoring and evaluation of studies to assure compliance with federal and institutional regulations
Develop and implement auditing programs, policies, procedures, documentation and systems in accordance with Federal, State and University mandates.
Assist in development of research designs, amendments, and evaluations and offers direction in implementation for collection of accurate data evaluation and analysis
Provides advice, guidance, and problem resolution to PI on protocol design/development and data collective mechanisms.
Conducts data analysis and provide written research analysis for project components on a regular bases.
Coordinate protocol submission to the Scientific Review Committee, Radiation Safety Committee, Biosafety Committee, and IRB
Original proposals are created that meet institutional and FDA regulations
New research proposals are prepared and processed according to regulations
Consent forms, amendments, continuing review applications, FDA, IND applications, SAE analysis and reports are prepared and processed according to regulations
Obtain input from local site's IRB representative to assure consideration of local context issues in different demographic regions as applicable
Develop and provide training and staff development on regulatory requirements and protocol design
Develop and deliver training on research protocols to ensure regulatory, and University compliance
Provide training to physicians, nurses, professors, teachers, data collectors, regulatory coordinators, and technicians and other staff involved in research studies in an understandable manner
Educational needs are identified based on audits and other information; develop and deliver training as needed
Provide instruction on the interpretation of test results, and observations
Implement data safety monitoring mechanisms ensuring regulatory standards are met and coordinate reporting to Data Safety Monitoring Committee while assisting with implementation of corrective measures based on findings of audit of studies.
Organizes and performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines
Analyze data and prepare audit reports and summaries, findings are presented to the Committee(s)
Ensure databases to track human subject research are implemented and maintained
Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training with staff development for on-site and off-site personnel as required
Maintain a current knowledge of Federal, State, and University laws, regulations, guidelines governing human subject research
Represents human subject compliance programs on various groups and committees as appropriate
Conducts site visits (travel required)
Prestudy site visits are conducted as required
Evaluative reports are prepared
Site monitoring visits are conducted and followed-up to resolve identified problems
Files, records, case report forms, and source documents are reviewed for completeness, accuracy, and compliance; identifies deficiencies and discrepancies, and remedial training is provided as needed
Bachelor's Degree (or equivalent experience) and 5 years relevant experience
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
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
Â·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
Â·Truven Health Analytics:among the top 50 cardiovascular hospitals in the U.S.
Â·Becker's Hospital Review:one of the "100 Greatest Hospitals in America"
Â·The Leapfrog Group:grade "A" in Hospital Safety Score
Â·National Institutes of Health:among the top 10 grant awardees for medical research in the US
Â·Magnet Recognition Program:Vanderbilt nurses are the only group honored in Middle Tennessee
Â·Nashville Business Journal:Middle Tennessee's healthiest employer
Â·American Hospital Association:among the 100 "Most Wired" medical systems in the US
Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.