The University of Alabama at Birmingham (UAB), Division of Child Neurology in the Department of Pediatrics, is seeking a Clinical Research Nurse Coordinator II to coordinate studies within the division, working with multiple investigators across a broad spectrum of neurological disorders including children with neurodevelopmental, neuromuscular disorders, and epilepsy. Some studies may also involve adults with neurogenetic disorders. In addition to the day-to-day coordination of clinical studies, the person in this position will assist in billing clinical trial activities to those sponsors, assist with study startup, maintain regulatory documents for studies in their portfolio including IRB applications and monitor IRB training compliance, and use EPIC for research.

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

1. Manage the life cycle of the clinical trial from study start-up through trial maintenance to study closure.
2. Coordinate and organize patient care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
3. Maintain a working nursing knowledge of the division's specialty, draft documents, or policies, collect records, and assist with preparation of data for publication.
4. Follow the patient from referral, consent, screening, through treatment, and follow-up, providing patient and family education and maintaining records and documentation.
5. Coordinates management of investigational products (IP).
6. Perform phlebotomy under difficult circumstances Processes and maintains lab specimens.
7. Assists with the development of protocols.
8. Assists with study budgets as needed.
9. Manages sites' supplies as needed.
10. Assists with the development of documents related to patient safety and security.
11. Performs routine and complex clinical procedures as required by the protocol, as well as trains and oversees the performance of clinical procedures and protocols by other study staff.
12. Prepares for study monitoring visits, corrects findings as needed, and manages related contributions by other study staff.
13. Attends various department meetings and participates in multi-site investigator web meetings and training activities.
14. Develop study source documentation.
15. Complete regulatory aspects of the trials assigned, such as site feasibility questionnaires, FDA 1572, financial disclosure forms, gathering/filing study staff training CVs, submitting to OSP, submitting to local/central IRBs, etc.
16. Performs other duties as assigned.

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

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.