The University of Alabama at Birmingham (UAB), Department of Med - Immunology/Rheumatology, is seeking a Clinical Research Coordinator I.

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. 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, and 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. Managing project calendars and timelines with investigators and the 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. Will work with Rheumatology leadership to launch a 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, identify efficiencies, and improve 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. Will conduct research study activities, with oversight from Principal Investigator(s), in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
23. Will perform procedures as required by the protocol, including recruitment, screening, scheduling, consenting participants, conducting study visits, and collection of biospecimens.
24. Will conduct 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.
25. Will track study progress, assist with regulatory submissions (IRB), and maintain study regulatory records.
26. Will serve as a liaison to clinical staff, Principal Investigator(s), sponsor(s), internal and external collaborators.
27. Will attend study meetings and assist with the preparation of study reports.
28. Performs other duties as assigned.

Annual Salary Range

$43,890 - $60,000

Qualifications

High School diploma or GED required.

Preferences

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