Clinical Research Nurse Coordinator Ii (Part-Time)

General Responsibilities

• 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 Responsibilities

• Screens participants for all studies independently.
• Identifies and explains the risk and benefits to a subject as these pertain to a clinical trial.
• Employs strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
• Evaluates processes to identify issues related to recruitment and retention rates.
• Conducts and documents consent for participants in a variety of studies independently.
• Collects, prepares, processes, ships, and maintains inventory of research specimens and trains others in these tasks.
• Assists with addressing and correcting findings from study monitoring and study audit visits.
• Collects, prepares or processes adverse event information independently.
• Completes and submits adverse event reports.
• Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
• Develops UAB IRB documents such as consent forms, protocols, and continuing reviews independently.
• Communicates to research participants, both orally and written, the difference between clinical activities and research activities.
• Maps a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis.
• Uses Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
• Enters data accurately.
• Scores tests and measures according to protocol, and appropriate to role.
• Trains junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
• Uses required processes, policies, and systems to ensure data security and provenance.
• Recognizes and reports vulnerabilities related to the security of physical and electronic data.
• May serve as a mentor to other staff.
• Maintains training requirements and develops solutions to proactively ensure study team members' compliance with training requirements.
• Perform other duties as assigned.

Hourly Range - $29.25 - $47.55

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement. Currently licensed as a Registered Nurse (RN) by the AlabamaBoard of Nursing required.