T221594 - University of Alabama at Birmingham

The University of Alabama at Birmingham (UAB), 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, working with sponsors and monitors, and processing study samples.

General Responsibilities

• To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
• To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
• To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
• To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

1. Studies sample preparation, ensuring proper labeling and documentation.
2. Performs quality control checks, records processing steps, operates and maintains laboratory equipment, adheres to laboratory safety protocols, works closely with laboratory researchers, and maintains accurate and comprehensive documentation of standard operating procedures.
3. Maps a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis.
4. Uses Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
5. Enters data accurately.
6. Scores tests and measures according to protocol and to the appropriate role.
7. Independently maintains appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
8. Develops UAB IRB documents such as consent forms, protocols, and continuing reviews independently.
9. Communicates to research participants, both orally and written, the difference between clinical activities and research activities.
10. Collects, prepares, processes, ships, and maintains inventory of research specimens and trains others in these tasks.
11. Assists with addressing and correcting findings from study monitoring and study audit visits.
12. Collects, prepares, or processes adverse event information independently.
13. Completes and submits adverse event reports.
14. Screens participants for all studies independently.
15. Identifies and explains the risks and benefits to a subject as these pertain to a clinical trial.
16. Employs strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
17. Evaluates processes to identify issues related to recruitment and retention rates.
18. Conducts and documents consent for participants in a variety of studies independently
19. Performs other duties as assigned.

Annual Salary Range:%2443,890 - %2471,320

High School diploma or GED 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, religion, sexual orientation, gender identity, gender expression, and veteranrsquo;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 UABrsquo;s Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.