CLINICAL RESEARCH REGULATORY COORDINATOR III

The University of Alabama at Birmingham (UAB), Department of Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Regulatory Coordinator III.

This job position functions as a senior-level regulatory specialist with UAB regulatory expertise. This is considered a lead position, and the candidate must understand he/she is also responsible for reporting metrics (timelines, trends, compliance-related issues), timeliness (meeting deadlines), and providing leadership and/or training to junior staff. Core responsibilities include project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events). Responsibilities also include documentation oversight (regulatory binders, eISFs, logs, etc.), ensuring all documents meet ICH-GCP, FDA, OHRP, and UAB policies, and compliance monitoring (must be knowledgeable of federal regulations, human subjects protections, HIPAA, and informed consent processes).

General Responsibilities

• To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• To prepares and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).

• To lead the implementation of study specific regulatory processes of a moderate to complex nature.

• To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.

• To design and implement quality initiatives ensuring effective and efficient clinical processes.

Key Duties & Responsibilities

1. Subject matter expert for complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation.

2. Prepares for and helps lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits. Identifying compliance gaps and implementing processes for corrective action planning is required.

3. Maintains standardized regulatory practices across multiple studies with multiple PIs is required. Must be competent in using a variety of electronic platforms as well as competent in the knowledge of FDA regulations, HSP, UAB research processes, and IRB submission processes.

4. Performs other duties as assigned.

Annual Salary Range\: $55,180 - $71,735