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

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, collects, prepares, processes, ships, and maintains inventory of research specimens and trains others in these tasks.

2. Assists with addressing and correcting findings from study monitoring and study audit visits.

3. Collects, prepares, or processes adverse event information independently.

4. Completes and submits adverse event reports.

5. Independently maintains appropriate study-level documentation, including regulatory binders, enrollment logs, patient registration in the system of record, etc.

6. Develops UAB IRB documents such as consent forms, protocols, and continuing reviews independently.

7. Communicates to research participants, both orally and written, the difference between clinical activities and research activities.

8. Prepares ad hoc or recurring reports for publication or presentation periodically or as needed. Conducts literature reviews.

9. Creates data entry instructions and trains data entry personnel.

10. Assesses and determines solutions for operational shortcomings of data procurement in protocol design.

11. Manages junior staff in the ethical conduct of research and provides guidance in strategies used to maintain safety.

12. Uses required processes, policies, and systems to ensure data security and provenance.

13. Recognizes and reports vulnerabilities related to the security of physical and electronic data.

14. Maintains training requirements and develops solutions to proactively ensure study team members' compliance with training requirements. May perform a variety of statistical analyses and summarize results.

15. Performs other duties as assigned.

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

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.

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.