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. The link to our website is: https://www.uab.edu/onealcancercenter/

Please attach a current resume with this application.

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

1. Conducts and understands all study activities including more complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
2. Develops or provides input for IRB documents.
3. Manages the life cycle of the clinical trial from study start-up through trial maintenance to study closure.
4. Performs complex clinical procedures as required by the protocol.
5. May serve as a resource person or acts as a subject matter expert (SME) within area of clinical expertise.
6. Maintains clinical records and documentation.
7. Mentors and trains junior staff as needed.
8. Coordinates management of investigational products (IP).
9. Designs best practices for management of IP for drug, device, and biologic studies.
10. Creates study budgets as needed.
11. Stays familiar with institutional financial systems.
12. Provides direction for preparation of study monitoring visits and correct findings as needed.
13. Develops study source documentation.
14. Assists with the development of protocols.
15. Assists colleagues in identifying efficiencies and improving processes.
16. Mentors and trains junior staff as needed.
17. Coordinates management of investigational products (IP).
18. Designs best practices for management of IP for drug, device, and biologic studies.
19. Stays familiar with institutional financial systems.
20. 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 study patients' care.
• Knowledge of regulatory/compliance affairs as it pertain to clinical research.
• Knowledge of protocol financial functions. Experience training and mentoring clinical research nurses.