JOB SUMMARY : Advanced knowledge and understanding of the planning, implementation and management of research operations. 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 processes, integrity and quality of the research are assessed and maintained and that the trial 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 and ensuring 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
Responsible for All Aspects of Site Management as Defined in the Project Plan
Understands, implements, and ensures compliance with clinical/translational study protocols on multiple studies coordinated across multiple sites independently and escalating potential issues as needed
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites. Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner
Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
Utilizes or acquires knowledge of disease processes as applicable for adequate tracking and reporting of safety (adverse events) and disease responses in a timely and accurate manner to the principal investigator, DSMC and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
· Bachelor's Degree (or equivalent experience) and 5 years of clinical research monitoring experience **including pre-study, site initiation, routine monitoring and closeout visits**
Additional Qualification Information: Accredited Research Discipline Specific (eg SOCRA, ACP) Required
Master's or Doctorate degree may be substituted for the accredited research discipline specific certification. In lieu of degree, candidates with 8 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
· Day Shift/Exempt Position
VICC is one of 50 National Cancer Institute-designated Comprehensive Cancer Centers, dedicated to an integrated and patient-focused approach to cancer research, treatment, support, prevention, education and outreach. The Clinical Trials Shared Resource (CTSR) provides services to assist Cancer Center investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner . http://www.vicc.org/
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.
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 ), 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 US
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.