Coordinate and participate in clinical research studies in diabetes and obesity conducted by principal investigator; involved in the recruitment, conduction metabolic research studies, collection, compilation, documentation of clinical research data. Assist in the determination of guidelines for the collection of clinical data and/or administration of clinical studies.
Screening and recruitment of subjects, evaluation and obtaining informed consents, and scheduling exams. Coordinate and implement research procedures requiring nursing skills. Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation and communications with subjects. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and Monitor patients’ progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
Evaluate and interpret collected clinical data in conjunction with principal investigator as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Confer with principal investigator to assist in developing plans for research projects and to discuss the interpretation of results. Coordinate the development of forms, questionnaires and the application of research techniques; assist in writing procedures manuals for data collection and coding. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
Assure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH or other funding agencies, and applicable regulations for the reporting of events to regulatory agencies. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes Maintain primary responsibility of a variety of regulatory tasks including coordination in assessment, completion, and submission of protocol related documents to the appropriate committees and Institutional Review board, maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CVs, licenses, site laboratory certifications) coordinate Human Protections Training for personnel.
Coordinate performing regulatory audits on cooperative group, industry sponsored, and Investigator Initiated protocols at clinical and affiliate sites, and submission of findings and recommendations in writing. Develop work plans to address findings. Work closely with sponsor and study personnel on relevant regulatory issues. Develop Policies and Procedures pertaining to regulatory processes. Lead regulatory and clinical educational events for personnel involved in research.
Associates degree with a current Texas RN license and three years nursing experience in the designated study area.
Knowledge of patient care, coordination and implementation of metabolic research studies, and IRB submission using specific website. The ability to effectively utilize word processing programs (Microsoft Word), graphics programs (MS Power Point), spreadsheet programs (MS Excel), and electronic database (e.g. Redcap) is required. Education and Experience Requirements LPN / BSN / MSN/ DNP Certification in ACRP / SoCRA (or equivalent) preferred.
Internal Number: 20164064
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