Clinical Research Regulatory Coordinator Ii Job University area,Florida USA,Healthcare

Position: CLINICAL RESEARCH REGULATORY COORDINATOR II (2)

CLINICAL RESEARCH REGULATORY COORDINATOR II

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator II. This position will report to the Director of Quality Management. Responsibilities include reviewing data from clinical trial initiation through the trial’s duration, ensuring compliance with O'Neal Comprehensive Cancer Center standards and all applicable regulations, and maintaining regulatory documentation. The role supports quality assurance compliance with study protocols, ensures study guidelines are followed in accordance with Good Clinical Practices, and emphasizes regulatory documents.

General

Responsibilities

Prepare, submit, and assist with multiple levels of research documentation (i.e., 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.
Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
Assist in drafting compliant advertisements.
Serve as resource person or act as consultant within the area of regulatory expertise.

Key

Duties & Responsibilities

Verify compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH, and GCP regulations.

Maintain QA data files.

Prepare accurate audit reports, make recommendations for corrective actions with input/review from Director of Quality Management.

Assist with follow‑up on sponsor and internal audit queries, including writing Corrective and Preventive Actions (CAPA) when applicable.

Escalate and present major findings to the Director of Quality Management.

Identify needed training programs for clinical research staff based on QA review and reports.

Responsible for Quality Management and preparation of study‑related material for FDA, EMA, and Sponsor audits with assistance as necessary.

When applicable, participate in pre‑study meetings as QA representative.

Evaluate and present QA findings/metrics to appropriate staff members and managers.

Perform other duties as assigned.

Annual Salary Range: $47,665 - $77,455

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 are imperative.
Skilled in maintaining/reviewing records.
Skilled in developing and maintaining effective working relationships with staff.
Ability to work independently as well as within a team.
Ability to communicate effectively with peers, physicians, and management both orally and in written form.
Must be self‑directed/self‑motivated.
Skill in time management and executing workload with minimal supervision.

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 /titleix.

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