CLINICAL RESEARCH REGULATORY COORDINATOR II (3)

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

Job summary

A leading cancer center in the U.S. is seeking a Clinical Research Regulatory Coordinator II. The role involves preparing research documentation, coordinating IRB submissions, and maintaining regulatory compliance. Ideal candidates will have a Bachelor's degree and relevant experience in clinical research.

Qualifications

• Three years of related experience required.
• Advanced knowledge of clinical trial regulations preferred.

Responsibilities

• Prepare and submit research documentation including IRB submissions.
• Maintain regulatory documentation and draft informed consent documents.
• Prepare and maintain FDA applications for INDs and IDEs.

Skills

Effective communication skills

Ability to work independently

Education

Bachelor's degree in a related field

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR II (3) (T227903)

CLINICAL RESEARCH REGULATORY COORDINATOR II (3) - ( T227903 )

Description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator II to prepare, submit, and assist with various research documentation, including IRB submissions to UAB, WIRB, Advarra, and others.

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 the Deep South. This designation provides access to leading-edge treatments and clinical trials for patients, which can be vital for survival. The center supports over 400 scientists and physician-scientists, cares for 20,000 patients annually, and employs more than 160 staff members. More information can be found at: https://www.uab.edu/onealcancercenter/

Please attach a current resume with your application.

General Responsibilities

• Prepare, submit, and assist with 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 consent documents.
• 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 consultant within the area of regulatory expertise.

Key Duties & Responsibilities

• Maintain regulatory documentation including ICF, protocol, 1572, CVs, investigator brochures, recruitment materials, submission forms, and draft informed consents.
• Prepare and maintain FDA applications for INDs and IDEs.
• Act as a resource person or consultant within regulatory expertise.
• 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 are required. Work experience may substitute for the education requirement.

Preferences

• Advanced knowledge of regulations related to clinical trials and retrospective IRBs.
• Basic knowledge of clinicaltrials.gov, consenting, protocol review, adverse and serious adverse event reporting.
• Ability to work independently, make decisions, and interact with sponsors, regulatory authorities, and investigators.
• Effective communication skills with physicians, sponsors, and collaborators.

Primary Location

University

Job Category

Clinical Research

Organization

UAB

Employee Status

Regular

Shift: Day/1st Shift

Work Arrangement: Hybrid Eligible

UAB is an Equal Opportunity/Affirmative Action Institution. Concerns can be directed to UAB’s Title IX Coordinator. More info at uab.edu/titleix.