University of Alabama at Birmingham
CLINICAL RESEARCH REGULATORY COORDINATOR II (2)
University of Alabama at Birmingham, El Paso, Texas, United States
CLINICAL RESEARCH REGULATORY COORDINATOR II (2)
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator II. This role reports to the Director of Quality Management and is responsible for reviewing study data and regulatory files throughout the trial’s duration, ensuring compliance with O'Neal Comprehensive Cancer Center standards, applicable regulations, and Good Clinical Practices.
General Responsibilities
Prepare, submit, and assist with multiple levels of research documentation such as IRB submissions, educational materials, reports, grant renewal reports and study forms.
Maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports and submission forms.
Draft informed consents, FDA applications for INDs and IDEs, and compliant advertisements.
Serve as resource person or consultant within regulatory expertise area.
Key Duties & Responsibilities
Verify compliance with protocols, SOPs, FDA, ICH and GCP regulations.
Maintain QA data files and prepare accurate audit reports.
Provide recommendations for corrective actions and assist with follow-up on sponsor and internal audit queries, including drafting CAPA when applicable.
Escalate and present major findings to the Director of Quality Management.
Identify training needs for clinical research staff based on QA review and reports.
Prepare study‑related material for FDA, EMA and sponsor audits.
Participate in pre‑study meetings as QA representative.
Evaluate and present QA findings/metrics to staff and managers.
Perform other duties as assigned.
Qualifications Bachelor’s degree in a related field and three (3) years of related experience required (work experience may substitute for the education requirement).
Preferences
Knowledge of ICH‑GCP guidelines.
Accuracy, thoroughness and attention to detail.
Skilled in maintaining and reviewing records.
Skilled in developing and maintaining effective working relationships with staff.
Ability to work independently and within a team.
Effective oral and written communication with peers, physicians and management.
Self‑directed and self‑motivated.
Time‑management and workload execution with minimal supervision.
Job Details Primary Location: University. Job Category: Clinical Research. Organization: 310008400 Comprehensive Cancer Center. Employee Status: Regular. Shift: Day/1st Shift. Work Arrangement: Remote/Hybrid Eligible. Annual Salary Range: $47,665 – $77,455.
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, ethnicity or national origin, sex, 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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General Responsibilities
Prepare, submit, and assist with multiple levels of research documentation such as IRB submissions, educational materials, reports, grant renewal reports and study forms.
Maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports and submission forms.
Draft informed consents, FDA applications for INDs and IDEs, and compliant advertisements.
Serve as resource person or consultant within regulatory expertise area.
Key Duties & Responsibilities
Verify compliance with protocols, SOPs, FDA, ICH and GCP regulations.
Maintain QA data files and prepare accurate audit reports.
Provide recommendations for corrective actions and assist with follow-up on sponsor and internal audit queries, including drafting CAPA when applicable.
Escalate and present major findings to the Director of Quality Management.
Identify training needs for clinical research staff based on QA review and reports.
Prepare study‑related material for FDA, EMA and sponsor audits.
Participate in pre‑study meetings as QA representative.
Evaluate and present QA findings/metrics to staff and managers.
Perform other duties as assigned.
Qualifications Bachelor’s degree in a related field and three (3) years of related experience required (work experience may substitute for the education requirement).
Preferences
Knowledge of ICH‑GCP guidelines.
Accuracy, thoroughness and attention to detail.
Skilled in maintaining and reviewing records.
Skilled in developing and maintaining effective working relationships with staff.
Ability to work independently and within a team.
Effective oral and written communication with peers, physicians and management.
Self‑directed and self‑motivated.
Time‑management and workload execution with minimal supervision.
Job Details Primary Location: University. Job Category: Clinical Research. Organization: 310008400 Comprehensive Cancer Center. Employee Status: Regular. Shift: Day/1st Shift. Work Arrangement: Remote/Hybrid Eligible. Annual Salary Range: $47,665 – $77,455.
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, ethnicity or national origin, sex, 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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