This position is responsible for supervising research nursing personnel (i.e. Nurse Researchers, Sr. Research Support Specialist, and Research Assistants). Utilizes education and expertise to oversee patient-related services and activities to help enhance the clinical research opportunities in the Diabetes Center.
Supervise and manage USF Diabetes and Endocrinology Center clinical research personnel (including clinical research nurses) and provide leadership through program development and oversight, and support of Center clinical research activities. Manages leave and time policies, reviews and approves leave requests for staff; evaluates staff performance; and recommends further action if performance is substandard. Provides training and support to research staff for clinical systems. Work in concert with the Clinical Director to supervise the clinical research team and to assess the clinical research program's current and future needs, i.e. infrastructure, staff, and supplies, dependent upon the number and nature of clinical research protocols. Investigates and resolves subject and staff complaints. Interviews prospective and new clinical research employees; ensures proper orientation and training for each employee. Establishes competency measures for
each position.
Consultation and coordination with Clinical Director to support the efforts of clinical research staff to evaluate potential research participants; schedule and perform screenings; explain consent process; randomize participants into appropriate research study. Assist with coordination and scheduling of study visits and followups. Collect, analyze, and perform quality assurance of study data. Monitor overall clinical studies to ensure quality control measures are in compliance with protocol. Oversee ordering, dispensing and maintenance of supplies and study medications. Ensure consistent interpretation and adherence to protocols at all stages of trials by team members. Perform procedures as necessary, such as venipuncture, electrocardiograms, quantitative Sensory Testing, glucose/insulin testing, etc. as required per protocol.
Support TrialNet Affiliate Center activities, including conduct of ongoing clinical trials, communication with the TrialNet Coordinating Center, and the UF Clinical Center.
Coordinate correspondence with research sponsors, including completion of feasibility questionnaires, oversight of query responses. Work with the USF Office of Clinical Research in preparing and negotiating research study budgets.
Collaborate in development of new research grants; work with USFD&EC principal investigators to prepare and submit protocol applications, amendments, annual reviews, Adverse Event reports, and study sponsor communications to IRB as required. Provide clinical nursing consultation in the development of protocols, research instrument design, coding, analysis and selection of assessments.
Recommend changes in protocols to improve quality of data gathering or overall study. Cover evening and weekend research visits (when necessary) and outreach events. Assist in planning and performing research subject recruitment/screening at appropriate outreach events including camps/walks, and
education/support events for patients, families, and care providers Actively travel to and participate in research study meetings, as required, to discuss progress/status of study.
Oversee USF Diabetes and Endocrinology Center Research protocol regulatory compliance, including IRB submission and correspondence. Utilize principles of Problem Oriented Recording (POR) and Subjective Objective Assessment Planning (SOAP) to diagnose and document patient records.
Recognize physical or emotional abnormalities that require immediate referral and takes appropriate action. Assist physician or nurse practitioner with special exams and procedures. Administer medication, vaccines, and injections per protocol or physician order; records administration of medication. Counsel patients in self-care prevention, treatment, and follow-up of problems.