CLINICAL RESEARCH REGULATORY COORDINATOR II
Legal
university, fl, usa
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
Qualifications
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Preferences
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.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.