CLINICAL RESEARCH REGULATORY COORDINATOR III

About the role

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 they are also responsible for reporting metrics (timelines, trends, compliance-related issues), timeliness (meeting deadlines), and providing leadership and/or training to junior staff.

Responsibilities

• Project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events).
• 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).
• 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.
• Subject matter expert for complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation.
• To prepare for and help lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits.
• To identify compliance gaps and implement processes for corrective action planning is required.
• To maintain standardized regulatory practices across multiple studies with multiple PIs is required.
• Maintain 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.
• Performs other duties as assigned.

Requirements

• 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.
• Have strong project management and risk assessment skills.
• Communicate effectively with staff, investigators, sponsor representatives, legal officers, and other clinical trials administrative staff.
• Have strong computer skills, experience with Microsoft Office, engage in group meetings and discussions, able to work closely with others and under the leadership of Investigators and senior research coordinators in a variety of settings, and have a strong work ethic.
• Be knowledgeable of UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault.

Qualifications

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