CLINICAL RESEARCH REGULATORY COORDINATOR II

About the role

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

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, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms)
• To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms
• To draft informed consents
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs)
• To assist in drafting compliant advertisements
• To serve as resource person or act as consultant within area of regulatory expertise
• To prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents
• To prepare for and participate in calls and meetings, and participate in site visits with sponsors
• To prepare for, collect, and maintain documents for sponsor site visits
• To perform clerical duties (scan, fax, route documents, etc.)
• To maintain regulatory binders and licensures for clinicians
• To conduct QA audits for regulatory files
• To use electronic databases necessary for operations

Requirements

• Bachelor's degree in a related field and three (3) years of related experience required
• Work experience may substitute for education requirement
• Candidate is expected to be knowledgeable of the IRB submission process of complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation
• Candidate is expected to prepare and assist with lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits
• Identifying compliance gaps and implementing processes for corrective action planning is required
• Maintaining 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
• Must have strong project management and risk assessment skills
• Must be able to communicate effectively with staff, investigators, sponsor representatives, legal officers, and other clinical trials administrative staff
• Must possess great computer skills, have experience with Microsoft Office, be able to engage in group meetings and discussions, must be able to actively 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
• Must also be knowledgeable of UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault

Qualifications

• Knowledgeable of UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault