The University of Alabama at Birmingham (UAB), Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Coordinator III for the pulmonary research unit conducting clinical trials for cystic fibrosis and other pulmonary-related disorders.

General Responsibilities

• To serve as a lead coordinator by providing oversight to less experienced staff to ensure quality and regulatory compliance with clinical research operations.
• To coordinate and manage the research study lifecycle from start-up through close-out.
• To coordinate and conduct all applicable clinical and administrative activities required by the protocol such as screening, scheduling, consenting, assessing, ordering, collecting, documenting and shipping under the auspices of Good Clinical Practice (GCP).

Key Duties & Responsibilities

1. Manages all aspects of the research program and clinical studies, including education/training.
2. Develops protocol-specific systems and documents, including process flows, training manuals, SOPs, and CRFs.
3. Prepares study budgets as needed.
4. Coordinates studies of all complexities.
5. Acts as a consultant with clinical expertise.
6. Provides a lead role in determining participant eligibility.
7. In addition to creating study documentation, may provide oversight to junior staff members as well as for items such as source, lab, and pharmacy orders, flowsheets, and adverse events.
8. In conjunction with the PI or Director, interprets and applies current research findings in area of clinical specialty and reports findings in professional journals and local, state, and national conferences.
9. Identifies various stakeholders to ensure adequate design, implementation, and testing of study aims.
10. Prepares and submits multiple levels of research documentation (i.e., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
11. Collects information to determine study feasibility.
12. Makes recommendations to investigators and oversight organizations, as appropriate.
13. Maintains compliance with federal, state, and accrediting agencies (sponsors), including maintaining any required documentation.
14. May conduct literature reviews and contribute to assessing solutions for operational shortcomings of data procurement in protocol design.
15. May prepare for and lead team meetings.
16. Disseminates information related to studies, trainings, and general research operations as needed.
17. Assists colleagues in identifying efficiencies and improving processes.
18. Arranges multidisciplinary evaluations.
19. Performs other duties as assigned.

Annual Salary Range: $60,835 - $79,085

Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.