MANAGER-CLINICAL RESEARCH COORDINATION

The University of Alabama at Birmingham (UAB), General Internal Med & Population Science, is seeking a Manager-Clinical Research Coordination.

The Manager-Clinical Research Coordination will lead and support a growing portfolio of clinical research studies, primarily focusing on multi-site randomized controlled trials (RCTs). The research population will include both hospital-based and community-based participants. This position will oversee the clinical execution of research protocols while also serving as a sub-investigator or co-investigator on multiple studies, with the ability to directly engage with research participants and perform clinical tasks such as physical exams, adverse event evaluations, study drug administration (as appropriate), and protocol-specific assessments. The portfolio includes studies of moderate to high complexity, involving investigational products (drugs and devices), FDA-regulated trials, community-based behavioral interventions, and hybrid implementation-effectiveness trials. This role requires frequent interaction with multidisciplinary study teams, including principal investigators, project managers, regulatory staff, clinical research coordinators, data analysts, and community partners.

General Responsibilities

• To manage all aspects of research program and clinical studies including education/teaching.
• To oversee and manage multiple clinical research protocols and the associated personnel.
• To design best practices for management of IP for drug, device, and biologic studies.
• To prepare study budgets.
• To manage research staff within area including all applicable human resources functions.

Key Duties & Responsibilities

1. Provides oversight and training to the entire unit or department with regards to participant screening.
2. Sets up unit-wide systems, policies related to participant screening.
3. Provides oversight and training to the entire unit or department with regards to maintaining participant-level documentation.
4. Sets up unit-wide systems, policies related to participant-level documentation.
5. Creates unit-wide (and collaborates to create institution-wide) policies and guidance regarding the conduct of study visits.
6. Creates, optimizes, and oversees systems to collect, prepare, process, ship, and maintain inventory of research specimens and trains others in these tasks.
7. Designs the best methods for the management of IP.
8. Oversees implementation of and compliance with the required system for handling, dispensing, and documentation of IP for sponsored protocols.
9. Serves as an expert resource for study teams, UAB procurement, billing, and compliance for the proper handling of Investigational Product (IP).
10. Participates in or leads the development of policies and guidance related to study-level documentation.
11. Participates in or leads the development of policies and guidance related to participant recruitment.
12. Serves as an expert resource across the unit or department.
13. Participates in or leads the development of policies and guidance related to consent.
14. Participates in or leads the development of policies and guidance related to monitoring and audits.
15. Serves as an expert resource when addressing and correcting findings.
16. Oversees the collection of adverse event information for an entire unit or department.
17. Provides input for AE reports.
18. Serves as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms).
19. Liaises with the contact for the final determination of the safety event outcome.
20. Serves as a unit, department, or division resource for the development of IRB documents and guidance on IRB communications.
21. Serves as a resource for the development and implementation of RDSPs and DSMPs, and COIs across multiple studies or study teams.
22. Articulates, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
23. Predicts areas of vulnerability for data flow for multiple studies or across a unit, department, or division.
24. Designs data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at the unit, department, or division level.
25. May assist with the development of, or develop, guidance and policies related to research data provenance and security.
26. Serves as a unit/departmental resource to others regarding data provenance and security.
27. Develops system/framework for QA processes for multiple studies or for the entire unit.
28. Develops unit/department-wide quality assurance systems for research data; oversees implementation.
29. Performs other duties as assigned.

Annual Salary Range: $77,640 - $126,170

Qualifications

Bachelor's degree in a related field and eight (8) 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 strongly preferred.

Preferences

• Strong Clinical Insight: Deep understanding of clinical procedures, patient safety monitoring, adverse event reporting, and study assessments, with the ability to guide and troubleshoot study implementation alongside licensed providers.
• Leadership Team Management: Demonstrated ability to lead and manage multidisciplinary research teams, support protocol adherence, and maintain high-quality operations across multiple concurrent studies.
• GCP and Regulatory Compliance: Thorough knowledge of Good Clinical Practice (GCP), FDA and IRB regulations, and clinical trial SOPs; experience supporting or overseeing regulatory submissions and audits.
• Multi-Study Oversight: Ability to work across several clinical trials simultaneously, including those involving investigational products, behavioral interventions, and community-based delivery models.
• Communication Collaboration: Excellent communication and interpersonal skills to interface with investigators, coordinators, clinical partners, sponsors, and study participants.
• Analytical Problem-Solving Skills: Strong organizational skills with a proactive approach to identifying challenges and developing real-time solutions during trial execution.
• Technical Proficiency: Proficiency with clinical trial systems such as REDCap, OnCore, and CTMS platforms; comfort with electronic health records and data abstraction tools.