T208394 - University of Alabama at Birmingham

To serve as primary coordinator for clinical research studies and supporting more senior team members. To provide a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance. May provide oversight to junior clinical research coordinators (CRC) and clinical research nurse coordinators (CRNC) in review of study documents. To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP). To provide quality care to participants and their families within the area of clinical specialty. To coordinate the life cycle of the study from start-up through maintenance to closure. To manage participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires. To perform the informed consent process following GCP. To act as a liaison between the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.

Primary Duties and Responsibilities

• Conducts and understands all study activities in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP)
• Manages the life cycle of the clinical trial from study start-up through trial maintenance to study closure. Coordinates and organizes patient care, including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
• Promotes continuity of care through consultations with patients' families, medical and nursing staff. Performs routine and complex clinical procedures as required by the protocol. Prepares for study monitoring visits and corrects findings as needed. May serve as a resource person within the area of clinical expertise
• Coordinates management of investigational products (IP). Processes and maintains lab specimens.
• Assists with the development of protocols. Creates study budgets as needed. Manages sitersquo;s supplies as needed
• Assists with the development of documents related to patient safety and security
• Performs other duties as assigned.

Annual Salary Range - %2460,835 - %2470,000

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirements. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required. IRB Clinical Trials are preferred.