The University of Alabama at Birmingham (UAB), Department of Ped - Neonatology, is seeking a Clinical Research Coordinator I. This position will provide and support all aspects of coordination for clinical research. Tasks will include subject screening, recruitment, consenting, protocol-driven nursing skills, data collection and assessments, AE and SAE assessments; communicating with the research team and the principal investigator, and working with sponsors and monitors; mentoring and training junior staff.

General Responsibilities

• To collect and record preliminary data for clinical research programs.
• To recruit and perform follow-up with research participants as protocols outline.
• To schedule visits according to research protocols.
• To assist in coordination of lab and fieldwork.
• To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

Key Duties & Responsibilities

1. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
2. Assist with addressing and correcting findings from study monitoring and study audit visits.
3. Collect, prepare, or process adverse event information independently.
4. Complete and submit adverse event reports.
5. Screen participants for all studies independently.
6. Identify and explain the risks and benefits to a subject as these pertain to a clinical trial.
7. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
8. Evaluate processes to identify issues related to recruitment and retention rates.
9. Conduct and document consent for participants in a variety of studies independently.
10. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
11. Develop UAB IRB documents such as consent forms, protocols, and continuing reviews independently.
12. Communicate to research participants, both orally and written, the difference between clinical activities and research activities.
13. Assist junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
14. Use required processes, policies, and systems to ensure data security and provenance.
15. Recognize and report vulnerabilities related to security of physical and electronic data. May serve as mentor to other staff.
16. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
17. Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis.
18. Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
19. Enter data accurately.
20. Score tests and measures according to protocol, and appropriate to the role.
21. Performs other duties as assigned.

Annual Salary Range: $41,175 - $66,915

High School diploma or GED required.