CLINICAL RESEARCH NURSE COORDINATOR I (3)

General Responsibilities

To serve as coordinator for clinical research studies and provides support to other study team members for research trials, studies, and projects within the confines of the study protocols as directed.

To support protocol screening and study participant eligibility determination, working with more senior study team members to ensure compliance.

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 assist with the life cycle of the study from start-up through maintenance to closure.

To coordinate and organize 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 among the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.

Key Duties & Responsibilities

• Conducts all study activities in accordance with the protocol, IRB regulations, and GCP.
• Captures and reviews medical history to determine compliance with eligibility requirements.
• Develops study source documentation.
• Performs the informed consent process following GCP.
• Assists with the life cycle of the study from start-up through maintenance to closure.
• Maintains clinical records and documentation including those associated with compliant billing practices.
• Performs clinical procedures as required by the protocol.
• In collaboration with others as needed, completes and submits Adverse Event (AE) and Serious Adverse Event (SAE) reports in a timely manner and in compliance with FDA, sponsor, and institutional requirements.
• Reports safety, clinical care, and/or study conduct issues to the appropriate parties.
• Tracks the study participant calendar and schedules/coordinates relevant visits and procedures.
• Participates in study meetings and conference calls.
• Schedules participant visits among the Principal Investigator (PI), pharmacy, or others as needed.
• Uses the electronic medical record (EMR) as needed, including reporting procedure results.
• Maintains a working nursing knowledge of the department specialty, drafts documents or policies, collects records, and assists with the preparation of data for publication.
• Performs other duties as assigned.

Qualifications

• Bachelor's degree in a related field required.
• Work experience may substitute for education requirement.
• Currently licensed or eligible to be licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
• Preferences:
• Bachelor of Science in Nursing (BSN) degree.
• Knowledge of Oncology, clinical research, protocol, and clinical trial management.