MANAGER-CLINICAL RESEARCH ADMINISTRATION

The University of Alabama at Birmingham (UAB), Surgery Chair Office, is seeking a Manager-Clinical Research Administration. This position will be responsible for integrating both regulatory and administrative protocol management, making it a hybrid between the two benchmarks. It includes a unique mission for building departmental capacity, including training and eventually supervising decentralized regulatory personnel.

General Responsibilities

• To act as a subject matter expert (SME) for faculty and staff regarding administrative duties for industry and sponsored clinical research.
• To serve as a referral resource for the clinical research community at UAB.
• To manage and maintain the study s compliance with institutional requirements.
• To manage division-wide training in ethical conduct of research.
• To manage, assess and determine solutions for operational shortcomings of protocols.
• To provide human resources oversight for subordinate personnel.

Key Duties & Responsibilities

1. Regulatory Support IRB Submission Management: Prepare, submit, and maintain IRB applications, amendments, continuing reviews, reportable events, and closeout documents. Ensure all regulatory submissions meet federal, institutional, and IRB requirements. Maintain regulatory records in IRAP, OnCore, and other institutional systems. Monitor deadlines for ongoing compliance and ensure timely submissions.
2. Protocol Lifecycle Management: Coordinate protocol activities from study concept through closeout. Track study progress and ensure required documents are updated throughout the study lifecycle. Troubleshoot delays or issues affecting study feasibility and activation. Work with investigators to ensure protocol processes are followed consistently.
3. Department Level Guidance Central Point of Contact: Serve as the centralized resource for Department of Surgery investigators conducting human subjects research. Provide expert interpretation of IRB policies, institutional requirements, and regulatory expectations. Reduce duplicated effort by standardizing tools, templates, and processes used across divisions. Offer individualized support for faculty, trainees, and staff initiating new research.
4. Training, Onboarding Education: Develop, deliver, and update training sessions on IRB processes, regulatory compliance, and ethical conduct of research. Provide onboarding support for new research personnel, including trainees designing their first projects. Maintain departmental educational materials and ensure personnel meet certification requirements.
5. Quality Assurance, SOP Development, Compliance Monitoring: Conduct periodic quality checks of regulatory files and documentation. Recommend and help implement corrective actions for identified compliance gaps. Assist in developing and maintaining SOPs related to human subjects research within the department. Promote standardization and continuous improvement across divisions.
6. Collaboration, Process Improvement, Future Oversight: Coordinate with division-level regulatory staff to ensure consistent departmental standards. Assess departmental needs and recommend operational improvements in research workflow. Support long-range planning related to regulatory staffing and research infrastructure. Provide mentorship and eventual oversight to junior or division-specific research regulatory personnel as the department grows.
7. Perform 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

• Prior management experience in a Clinical Research Regulations role with protocol oversight and staff training.
• Responsible for providing department-level support essential for ensuring compliance, promoting efficiency, and preventing avoidable delays in research progress.