Under limited supervision, responsible for actively facilitating clinical research by administering and monitoring treatment or research protocols. Coordinates and participates in clinical research studies conducted by principal investigator; coordinates and participates in a variety of complex activities involved in the recruitment, collection, compilation, documentation and analysis of clinical research data. Assists in the determination of guidelines for the collection of clinical data and/or administration of clinical studies. May lead or mentor lower level team members. Communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders. Demonstrated ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner. Demonstrated ability to monitor important and complex projects concurrently. Ability to work independently with minimal supervision. Education Associate's Degree is required. Screens, recruits and consents study participants, verify eligibility, complete screening procedures, schedule and conduct study visits, collect and process data collection, complete CRF forms, complete electronic data entry and maintain study subject data. Instructs and counsels patients in research procedures, administers treatment procedures, monitors patients during procedures, and records and analyzes data. Frequently evaluates patient and collaborates with physicians to ensure goal specific plan of care. Reviews potential research studies for feasibility. Prepares and maintains regulatory documents, completes submissions for new studies, amendments, annual progress reports and final reports to various internal/external agencies such as

UTHSCSA IRB, NCI

Central

IRB, FDA

(if investigator initiated study), VA and University Hospital research offices. Ensures compliance with all federal and local regulations and that all regulatory processes are correct and align with policies of UTHSCSA as well as various research organizations. Monitors close-out of studies and ensures records are retained for appropriate length of time. Reviews goals and requirements of any new protocols; plans and designs source documentation for protocol; and coordinates study initiation. Coordinates and manages clinical research projects for Principal Investigator via study protocol including assessment, planning, evaluation and intervention for the well-being of study participants. Performs all other duties as assigned.