CLINICAL RESEARCH NURSE COORDINATOR II at UAB School of Health Professions

The University of Alabama at Birmingham (UAB), Med - Infectious Diseases, is seeking a Clinical Research Nurse Coordinator II.

CRNC II will participate in coordination of Phase 1-4 Infectious Diseases clinical research studies involving HIV negative and/or HIV-positive populations. This position is responsible for following study subjects from screening/enrollment through study completion. General responsibilities include management of study progress/timelines, communicating with study sponsors, reporting safety events, and managing the clinical aspect of studies while also performing general nursing duties.

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.

Key Duties & Responsibilities

The Department of Infectious Disease seeks a Clinical Research Nurse Coordinator II to manage the following duties:

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 correct findings as needed. May serve as a resource person within area of clinical expertise.
Coordinates management of investigational products (IP).
Processes and maintains lab specimens.
Assists with the development of protocols and study budgets as needed.
Manages site's supplies as needed.
Assists with the development of documents related to patient safety and security. QA/QC all study protocols weekly.
Assists the study team with preparing site reports. Informs study participants of their clinical research results as required.
Collects, compiles, and enters data into electronic databases and questionnaires.
Implements procedures, maintains records, tracks progress, and conducts quality assurance on study protocols and data collected.
Assists PI, Administrator, and Manager with regulatory submissions and maintaining documentation.
Works with Administrator and Manager to ensure data integrity and answer data queries.
Assists in coordination of recruitment and community engagement efforts.
Screens and enrolls participants in clinical research studies and clinical trials.
Conducts informed consent per GCP guidelines.
Conducts patient visits per protocol schedule of events.
Documents medications and procedures conducted at each visit.
Performs study procedures as trained.
Compiles and completes Case Report Forms (CRF) according to the protocol.
Prepares for study monitoring visits.
Attends project and required team meetings.
Performs other duties as assigned.

Annual Salary Range : $60,835 - $98,855

UAB School of Health Professions

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CLINICAL RESEARCH NURSE COORDINATOR II