CLINICAL RESEARCH NURSE COORDINATOR III (4)

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.

To 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 a study.

Key Duties & Responsibilities

• Conducts and fully understands all study activities, including more complex protocols, IRB regulations, and Good Clinical Practice (GCP).
• Develops or provides input for IRB documents.
• Manages the life cycle of clinical research studies from feasibility to start-up through maintenance to closure.
• Manages participant care, including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
• Determines compliance with eligibility requirements by developing or providing input for study source documentation.
• Performs the informed consent process following GCP.
• Performs clinical procedures as required by the protocol.
• Prepares for and participates in study monitoring visits and corrects and reports findings as needed.
• Serves as a resource person or acts as a subject matter expert (SME) within the area of clinical expertise.
• Maintains clinical records and documentation, including those associated with compliant billing practices.
• Assists with the development of protocols.
• Affords assistance in identifying inefficiencies and improving processes.
• Mentors and trains junior staff as needed.
• Coordinates management of investigational products (IP).
• May design best practices for management of IP for drug, device, and biologic studies.
• Creates study budgets as needed.
• Stays familiar with institutional financial systems.
• May perform general nursing duties.
• Performs other duties as assigned.

Qualifications

• Bachelor's degree in a related field and five (5) years of related experience required.
• Work experience may NOT substitute for education requirement.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
• Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
• Strongly prefer Oncology and/or Clinical Research experience, coordinating research activities involved in conducting Oncology clinical trials.
• Management of data and of the study patients' care.
• Knowledge of regulatory/compliance affairs as it pertains to clinical research.
• Knowledge of protocol financial functions.
• Experience in training and mentoring clinical research nurses.

Pay

Annual Salary Range: $67,070 - $108,990

Schedule

Day/1st Shift

Location

Organization 310008400 Comprehensive Cancer Center

Contact Information

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