CLINICAL RESEARCH REGULATORY COORDINATOR II

University of Alabama at Birmingham; Birmingham (AL); On-site; USD 47,665 - 77,455; Full time

Job summary

The University of Alabama at Birmingham is looking for a Clinical Research Regulatory Coordinator II to manage regulatory documentation and ensure compliance with research standards. This role involves mentoring junior staff and assisting with IRB submissions, FDA applications, and maintaining regulatory files.

The ideal candidate will have a bachelor's degree and three years of related experience, with strong skills in clinical trial operations and regulatory processes. Position is onsite in Birmingham, Alabama, offering a salary range from $47,665 to $77,455.

Qualifications

• Bachelor's degree in a related field and three years of related experience required.
• Work experience may substitute for education requirement.

Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation.
• Maintain regulatory documentation including consent forms and protocols.
• Draft informed consents and prepare FDA applications.
• Assist in drafting compliant advertisements.
• Conduct internal quality assurance audits of regulatory files.

Skills

Strong understanding of clinical trial operations

Regulatory processes

Communication skills

Organizational skills

Leadership skills

Education

Bachelor's degree in a related field

Tools

OnCore

RedCap

Job description

CLINICAL RESEARCH REGULATORY COORDINATOR II (T235996)

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator II.

Overview

The O'Neal Comprehensive Cancer Center is one of 51 NCI‑designated comprehensive cancer centers in the United States and is 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. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician‑scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. Link to website: https://www.uab.edu/onealcancercenter/

Key Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation (e.g., 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 INDs and IDEs.
• Assist in drafting compliant advertisements.
• Serve as resource person or consultant within regulatory expertise.
• Modify protocols and study documents as needed.
• Complete and submit safety reports and government documents.
• Enter protocol‑specific data into required institutional systems (IRAP, OnCore, and RedCap).
• Maintain appropriate licensure for clinicians.
• Conduct internal quality assurance audits of regulatory files.
• Oversee maintenance of Delegation of Authority logs.
• Maintain study compliance with institutional requirements.
• Assist colleagues in identifying efficiencies and improving processes.
• Serve as a mentor to junior regulatory staff; may train others and provide constructive feedback.
• 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

• Strong understanding of clinical trial operations, regulatory processes, OnCore, and RedCap data systems.
• Exceptional communication, organizational, and leadership skills.

EEO Statement

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.

Location and Work Arrangement

Primary Location: University
Job Category: Clinical Research
Employee Status: Regular
Shift: Day/1st Shift
Work Arrangement: Onsite