CLINICAL RESEARCH COORDINATOR I

The University of Alabama at Birmingham, Department of Med - Immunology/Rheumatology, is seeking a Clinical Research Coordinator I to join their team.

• 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.

1. Helps with patient screening, enrollment, follow-up, and completion of other study procedures in a high-paced environment.
2. Serves as a liaison with medical staff, University Departments, ancillary departments, and/or satellite facilities.
3. Helps with patient enrollment planning.
4. Conducts quality assurance activities.
5. Helps to develop and implement procedures, maintains records, tracks progress.
6. Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities.
7. Arranges access to study medications, including authorization for prescriptions.
8. Employs strategies to maintain recruitment and retention rates.
9. Manages project calendars and timelines with investigators and Research Team.
10. Helps prepare and submit multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
11. Works with Rheumatology leadership to launch large multi-site, national clinical trial. This includes assisting with finalization of study protocol, identification and contracting with external sites and preparing scientific reports for review by study sponsor and research community.
12. Helps manage investigational products (IP). Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
13. Provides data for the creation of study budgets as needed.
14. Completes Case Report Forms (CRF) according to protocol.
15. Assists with the development of standard operating procedures (SOPs) for data quality assurance.
16. Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures.
17. Under the oversight of the Investigator, helps develop protocols, identified efficiencies and improves processes.
18. Maintains compliance with federal, state and accrediting agencies (sponsors).
19. Maintains any required documentation.
20. Processes and maintains lab specimens.
21. Helps manage site supplies as needed.
22. Conducts research study activities, with oversight from Principal Investigator(s), in accordance with the protocol, IRB regulations and Good Clinical Practice (GCP).
23. Performs procedures as required by the protocol, including recruitment, screening, scheduling, consenting participants, conducting study visits and collection of biospecimens.
24. Arranges access to study medications, including authorization for prescriptions.
25. Employs strategies to maintain recruitment and retention rates.
26. Conducts various assessments and questionnaires, collect and enter data into electronic databases, such as REDCap and OnCore, as well as perform quality assurance on data collected.
27. Compiles data, helps to develop and implement procedures, maintains records and tracks progress.
28. Tracks study progress, assist with regulatory submissions (IRB) and maintain study regulatory records.
29. Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities.
30. Serves as a liaison to clinical staff, Principal Investigator(s), sponsor(s), internal and external collaborators.
31. Attends study meetings, assist with preparation of study reports.
32. Performs other duties as assigned.

• The ideal candidate has functional expertise in clinical and scientific environments.
• The individual would be organized, show attention to detail and has exceptional follow-through abilities.
• They will have clinical decision-making and assessment skills, enjoy face-to-face interactions with patients and study participants, and interfacing investigators and clinicians.