CLINICAL RESEARCH REGULATORY COORDINATOR II

University of Alabama at Birmingham; University (FL); Hybrid; USD 47,000 - 78,000; Full time

Job summary

Join a leading institution as a Clinical Research Regulatory Coordinator II, where your expertise in regulatory compliance will ensure the success of clinical trials. In this dynamic role, you will prepare and submit essential research documentation, maintain regulatory files, and conduct audits to uphold the highest standards of quality. This position offers the chance to make a significant impact on patient care through rigorous oversight and collaboration with clinical teams. If you are detail-oriented, self-motivated, and ready to contribute to groundbreaking research, this is the perfect opportunity for you!

Qualifications

• Bachelor's degree and 3 years of related experience required.
• Knowledge of ICH-GCP guidelines preferred.

Responsibilities

• Prepare and submit research documentation including IRB submissions.
• Conduct internal quality assurance audits of regulatory files.
• Assist in the design and implementation of quality initiatives.

Skills

Regulatory Compliance

Audit Skills

Attention to Detail

Communication Skills

Time Management

Education

Bachelor's degree in a related field

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR II (T223574)

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 the review of data from clinical trial initiation throughout the trial's duration, assuring compliance with the O'Neal Comprehensive Cancer Center standards and all applicable regulations with a strong emphasis on regulatory compliance.

Please attach a current resume with this application.

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 a resource person or act as a consultant within area of regulatory expertise.

Key Duties & Responsibilities

• Audit Investigator Initiated Trials (IIT), Cooperative trials, and pharmaceutical sponsored trials.
• Conduct internal quality assurance audits of regulatory files.
• Assist in the design and implementation of quality initiatives ensuring effective and efficient clinical processes.
• Verify compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH, and GCP regulations.
• Prepare accurate audit reports and make recommendations for corrective actions with input/review from the 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 quality assurance reviews and reports.
• Responsible for Quality Management and preparation of study-related material for FDA, EMA, and Sponsor audits.
• Participate in pre-study meetings as QA representative when applicable.
• Evaluate and present Quality Assurance 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 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, religion, sexual orientation, gender identity, gender expression, and veteran’s status.

Primary Location

University

Job Category

Clinical Research

Employee Status

Regular

Shift: Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager): Remote/Hybrid Eligible