BASIC FUNCTION

Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols in patients living with HIV in the UIHC Virology Clinic as part of the Ryan White Program. The position requires the academic knowledge of a specific discipline and professional licensure in a clinically-related field related to the study. Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility.

KEY AREAS OF RESPONSIBILITY

Research/Clinical Activities:

• Perform clinical/health care research activities in a skilled/specialized area.
• Screen patient for study eligibility and consent for clinical trials.
• Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.
• Coordinate patient care needs and obtain medical information from local physicians, labs or other providers assuring confidentiality of information according to UIHC policy and HIDAA regulations.
• Relay information to principle investigator and verify patient eligibility.
• Administer study medication and identify adverse reactions.

Protocol Development and Study Responsibilities:

• Assist in the design, development, execution, administration and maintenance of Virology Clinic protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assist patients with problems related to protocol. Oversee CRF development.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials.
• Serve as liaison to local health care practitioners, agencies, and sponsors.

Subject Recruitment and Enrollment:

• Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in a specialized area of research.
• Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Prepare study recruitment materials. Develop complex study recruitment materials.

Data Collection and Monitoring:

• Participate in the design; development and testing of clinical research trial data systems.
• Validate data and make recommendations for resolution.
• Revise and implement change in data collection.
• Obtain documentation of the hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol.

Regulatory Guidelines and Documents:

• Manage and organize regulatory documentation.
• Prepare regulatory submissions.
• Perform on-site audits of research and clinical data.
• Monitor compliance of regulatory guidelines and proper maintenance of documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• May recommend corrective action for reportable events.
• Maintain records and services provided and work within individual protocol budgets. Assist in writing and submission of initial and continuing reports to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research regulatory groups.

Human Resources/Leadership:

• May provide functional and/or administrative supervision.
• Mentor new staff under direction.

Financial Responsibility:

• Develop and administer budget for study(ies).
• Serve as a liaison to the University Business Office to identify exact patient tests and procedures, which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures.