CLINICAL RESEARCH NURSE COORDINATOR I

The University of Alabama at Birmingham (UAB), Ped - Neurology, is seeking a Clinical Research Nurse Coordinator I.

The Division of Child Neurology in the Department of Pediatrics has a position available for a lead Clinical Research Nurse Coordinator I to coordinate studies within the division, work 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 of clinical trial activities to those sponsors, will assist with study startup, will 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 coordinator for clinical research studies and provides support to other study team members for research trials, studies, and projects within the confines of the study protocols as directed.
• To support protocol screening and study participant eligibility determination, working with more senior study team members to ensure compliance.
• To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP). May provide quality care to participants and their families within the area of clinical specialty.
• To assist with the life cycle of the study from start-up through maintenance to closure. To coordinate and organize 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 among the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.

Key Duties & Responsibilities

1. Manages the life cycle of the clinical trial from study start-up through trial maintenance to study closure.
2. Coordinates and organizes patient care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
3. Maintains a working nursing knowledge of the division's specialty, drafts documents or policies, collects records, and assists with the preparation of data for publication.
4. Follows 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. Performs phlebotomy under difficult circumstances.
7. Processes and maintains lab specimens.
8. Assists with the development of protocols.
9. Assists with study budgets as needed.
10. Manages sites' supplies as needed.
11. Assists with the development of documents related to patient safety and security.
12. 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.
13. Prepares for study monitoring visits and corrects findings as needed, and manages related contributions by other study staff.
14. Attends various department meetings and participates in multi-site investigator web-meetings and training activities.
15. Develops study source documentation.
16. Completes 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.
17. Performs other duties as assigned.

Annual Salary Range : $52,555 - $85,400

Qualifications

Bachelor's degree in a related field required. Work experience may substitute for education requirement. Currently licensed or eligible to be licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.