In collaboration with the VU Human Research Protections Program, the Research Services Consultant II (RSC II) assists with the optimal application of the Federal, State, and local laws, guidance documents, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VU research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The RSC II researches topics of departmental, institutional or strategic importance.
Under the supervision of the Coordinating Center Manager within the Clinical Trials Shared Recourses Coordinating Center, the RSC II supports the clinical research efforts of the Vanderbilt-Ingram Cancer Center by providing oversight and project management for participating sites of our Investigator Initiated Trials, in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and Medical Center policies and procedures.
The NCI-designated Vanderbilt-Ingram Cancer Center (VICC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care. VICC provides research resources to its engaged faculty and offers multidisciplinary cancer care to its patients.
Responsibilities related to project coordination activities include independently managing start-up activities at the sponsor level, inclusive but not limited to, finalizing protocols for sponsor-investigators, submitting to internal and external committees (Food and Drug Administration [FDA], Scientific Review Committee [SRC], etc.) and funders. The setup and activation of outside vendors such as drug-depots and laboratories.
Additionally, the incumbent will be responsible for managing all components of the multi-site protocols. S/he will be responsible for developing protocol specific multi-site processes, checklists and templates for both standardization and ensure compliance with federal, state, and university regulations for the management and coordination for all investigator-initiated trials with sub-sites in collaboration with the Coordinating Center Manager.
In addition, the RSC II serves as the liaison to investigators, funders, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team Business Meetings, interacting with funding agencies including National Cancer Institute, and compliance and regulatory groups such as the Food and Drug Administration (FDA).
The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).
* Bachelor's Degree (or equivalent experience) and 6 years relevant experience
* Day Shift/ Exempt Position
* 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 50 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/
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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.
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
* T ruven Health Analytics: among the top 100 hospitals in the US
* Be cker'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 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.