CLINICAL RESEARCH REGULATORY COORDINATOR II
Description
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. 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, 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.
Key Duties & Responsibilities
Prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.
Prepares for and participates in calls and meetings, and participates in site visits with sponsors.
Prepares for, collects, and maintains documents for sponsor site visits.
Clerical duties (scan, fax, route documents, etc.).
Maintains regulatory binders and licensures for clinicians.
Conducts QA audits for regulatory files.
Use electronic databases necessary for operations
Performs other duties as assigned.
Annual Salary Range\: $47,665 - $61,965