CLINICAL RESEARCH REGULATORY COORDINATOR III

University of Alabama at Birmingham; Birmingham (AL); Hybrid; USD 55,000 - 90,000; Full time

Job summary

The University of Alabama at Birmingham is seeking a Clinical Research Regulatory Coordinator III to manage regulatory processes for clinical trials. Responsibilities include preparing documentation, conducting audits, and mentoring staff. This role offers a competitive salary and opportunities for professional growth.

Qualifications

• Five years of related experience required; certification preferred.
• Work experience may NOT substitute for education.

Responsibilities

• Prepare and submit research documentation including IRB submissions.
• Conduct internal quality assurance audits of regulatory files.
• Mentor junior regulatory staff and provide training.

Skills

Prioritization

Process improvement

Quality assurance

Communication

Critical thinking

Education

Bachelor's degree in a related field

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR III (T226735)

CLINICAL RESEARCH REGULATORY COORDINATOR III - ( T226735 )

Description

The University of Alabama at Birmingham (UAB), Comprehensive Cancer Center, is seeking a skilled Clinical Research Regulatory Coordinator III to join their team. The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. The O'Neal Cancer Center is a significant part of Birmingham's economic landscape, supporting over 400 scientists and physician-scientists, caring for 20,000 patients annually, and employing more than 160 staff members, including physicians and clinical staff. More information can be found on our website: https://www.uab.edu/onealcancercenter/.

General Responsibilities

1. Prepare and submit research documentation including IRB submissions, educational materials, reports, grant renewal reports, and study forms.
2. Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
3. Lead the implementation of study-specific regulatory processes of moderate to complex nature.
4. Conduct internal quality assurance audits of regulatory files, programs, reports, and teams involved in clinical trial operations.
5. Design and implement quality initiatives to ensure effective and efficient clinical processes.

Key Duties & Responsibilities

1. Prepare and submit research documentation (IRB submissions, reports, grant renewals, etc.).
2. Maintain FDA applications for INDs and IDEs; lead regulatory process implementation.
3. Conduct quality assurance audits of regulatory files and clinical trial teams.
4. Develop and oversee SOPs; improve processes as needed.
5. Write reports, business correspondence, and procedure manuals; plan and deliver training sessions.
6. Mentor junior regulatory staff and provide training and feedback.
7. Serve as liaison with medical staff, university departments, IRB, sponsors, and satellite facilities.
8. Ensure compliance with licensure requirements for clinicians.
9. Participate in committees and stay active in regional and national forums.
10. Perform additional duties as assigned.

Salary Range: $55,180 - $89,670

Qualifications

Bachelor's degree in a related field and five (5) years of related experience are required. Work experience may NOT substitute for education. Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is preferred.

Preferences

• Knowledge of ICH-GCP guidelines.
• Experience with IRB regulations and FDA processes.
• Strong problem-solving skills across various clinical studies.
• Expertise in scientific and clinical terminology.
• Ability to work independently and as part of a team.

Key Skills

• Prioritization and organizational skills.
• Process improvement and quality assurance skills.
• Excellent written and verbal communication skills.
• Critical thinking abilities.

Primary Location

University

Job Category

Clinical Research

Employee Status

Regular

Shift: Day/1st Shift

Work Arrangement: Remote/Hybrid Eligible

Equal Opportunity Statement: UAB is committed to providing equal employment and educational opportunities to all individuals regardless of race, color, religion, national origin, sex (including pregnancy), age, disability, veteran’s status, or genetic information. Concerns can be reported to UAB’s Title IX Coordinator. More information is available at uab.edu/titleix.