CLINICAL RESEARCH NURSE COORDINATOR III (4)

Clinical Research Nurse Coordinator III

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Nurse Coordinator III. The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care.

General Responsibilities:

• Serve as primary coordinator for clinical research studies and supporting more senior team members.
• Provide a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.
• Provide oversight to junior clinical research coordinators (CRC) and clinical research nurse coordinators (CRNC) in review of study documents.
• Conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP).
• Provide quality care to participants and their families within the area of clinical specialty.
• Coordinate the life cycle of the study from start-up through maintenance to closure.
• Manage participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
• Perform the informed consent process following GCP.
• 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.
• Documents and reviews medical history to determine compliance with eligibility requirements.
• Develops/prepares 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.
• Develops study source documentation.
• Assists with the development of protocols.
• Assists colleagues 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.
• Maintains a working nursing knowledge of the department specialty, drafts documents or policies, collects records, and prepares data for publication, if needed.
• May perform general nursing duties.
• Performs other duties as assigned.

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

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.
• Preferences: 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.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.