Job Description

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. Core responsibilities include assisting with project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events). Responsibilities also include assisting 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).

General Responsibilities

• To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• To assist with initial drafts of informed consent documents.
• To prepare regulatory binders and associated documentation.

Key Duties & Responsibilities

1. Prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.
2. Prepares for and participates in calls and meetings, and participates in site visits with sponsors.
3. Prepares for, collects, and maintains documents for sponsor site visits.
4. Clerical duties (scan, fax, route documents, etc).
5. Maintains regulatory binders and licensures for clinicians.
6. Conducts QA audits of regulatory files.
7. Uses electronic databases necessary for operations
8. Performs other duties as assigned.

Hourly Range : $18.85 - $24.50

Qualifications

High School diploma or GED required.

Preferences

• Candidate is expected to be 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.
• Candidate is expected to help 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.
• Must be able 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.
• Must have good 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, 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 or willing to learn 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.

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