The Division of Gastroenterology, Hepatology, and Nutrition at Vanderbilt University Medical Center is seeking a qualified Clinical Trials Associate to support and manage Dr. Doug Morgan's research in cancer epidemiology and prevention in Latin America and the U.S. His research has a specific focus on gastric cancer initiatives in Central and South America. The position will provide support in the management of studies including protocol and regulatory oversight, database and biobank management, and coordination of analysis with report and manuscript preparation. The individual will work closely with colleagues in Gastroenterology, Vanderbilt Institute of Global Health (VIGH), and Vanderbilt Ingram Cancer Center (VICC).
The position does require some travel to Central and South America, approximately 2 times a year for 1 week.
Proficiency in Spanish is preferred.
Coordinate review by Institutional Review Board of research proposals/protocols under which human subjects may be involved; compile protocol information, ensure compliance with federal regulations; support the activities of the Principal Investigator in accordance with federal, state, local, institutional, and any other appropriate guidelines, policies, and procedures.
Coordinate protocol and patient consent form process
Compile and analyze protocol information necessary to write IRB proposals and patient consent forms
Formulate, design, and revise research proposal forms which are to be completed by research investigators who intend to do research involving human subjects; serve as a resource to these investigators and others who are engaged in research and/or undergoing audits.
Write consent forms, conferring with PI and/or sponsor on language required. Ensure compliance with federal/IRB regulations
Ensure approval obtained from IRB as required
Review research proposals/protocols under which human subjects may be involved for conformity to university policy and Institutional Review Board requirements, and federal regulations.
Review proposals for completeness of preparation and presentation of adequate and appropriately related information
Ensure necessary forms, licenses, CVs, labs, are maintained and updated as required to meet regulatory guidelines
Contact sponsoring company if find error in protocol
Monitor accrual for study, ensuring compliance with protocol
Coordinate approval process with Committees
Communicate and coordinate with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
Ensure approvals obtained from Bio and Radiation Safety Committee and IRB Committee, and other regulatory committees, as required
Provide and maintain liaison with the university committee as the need arises; provide and maintain educational liaison with the investigators, PIs, and research analysts.
Manage and submit adverse effects forms to the IRB for approval, as required.
Compile annual reports for IRB on each research study. Provide new summary letter annually, as required.
Compose and submit Investigational New Drug Applications to the FDA for drugs needing FDA approval. Inform FDA of all revisions to the study and obtain IRB approval of revisions.
Maintain knowledge of federal regulations
Read various books, regulations, periodicals, and newspapers to keep informed
Attend conferences, seminars, symposiums, and classes
Perform administrative duties in support of the studies
Supervise clerical support staff to ensure that records and files are properly maintained and that the appropriate documentation is obtained when required
Maintain database to track protocols, NCI registration, amendment renewals, new submissions, approvals, INDs, outside safety reports, adverse event forms and other data necessary to ensure compliance with regulatory guidelines.
Manage cooperative and NCI registration
Develop policies and procedures to support process
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.