CLINICAL RESEARCH REGULATORY COORDINATOR I

About the role

The University of Alabama at Birmingham (UAB), Department of Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Regulatory Coordinator I. This job position is for an entry-level regulatory specialist.

Responsibilities

• Affixing assistance with project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events).
• Affixing assistance with 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 or willing to learn federal regulations, human subjects protections, HIPAA, and informed consent processes).
• Maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• Preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• Assistance in preparing initial drafts of informed consent documents.
• Preparation of regulatory binders and associated documentation.
• Prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.
• Participation in calls and meetings, and participation in site visits with sponsors.
• Preparation for and collection of documents for sponsor site visits.
• Performing clerical duties (scan, fax, route documents, etc.).
• Maintenance of regulatory binders and licensures for clinicians.
• Conducting QA audits of regulatory files.
• Utilization of electronic databases necessary for operations.
• Performing other duties as assigned.

Requirements

• High School diploma or GED required.
• Knowledgeable of or willing to learn IRB submission processes of complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation.
• Helping prepare and assist with lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits.
• Assisting with identifying compliance gaps and implementing processes for corrective action planning is required.
• Maintaining standardized regulatory practices across multiple studies with multiple PIs is required.
• Ability to use a variety of electronic platforms and be knowledgeable of or willing to learn and apply FDA regulations, HSP, UAB research processes, and IRB submission processes.
• Good project management and risk assessment skills.
• Effective communication skills, including the ability to engage in group meetings and discussions, work closely with others, and under the leadership of Investigators and senior research coordinators in a variety of settings.
• Knowledgeable of or willing to learn UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault.