CLINICAL RESEARCH REGULATORY COORDINATOR II (4)

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

Job summary

An established industry player is seeking a Clinical Research Regulatory Coordinator II to support vital research documentation and IRB submissions. This role is crucial in maintaining regulatory compliance and ensuring that clinical trials run smoothly. You will work closely with a team of dedicated professionals, contributing to groundbreaking cancer research and providing patients access to innovative treatments. If you have a passion for clinical research and regulatory affairs, this opportunity offers a chance to make a significant impact in the field while working in a supportive and dynamic environment.

Qualifications

• Bachelor's degree and 3 years of experience in clinical research required.
• Advanced knowledge in regulatory aspects of clinical trials preferred.

Responsibilities

• Prepare and submit research documentation and IRB submissions.
• Maintain regulatory documentation and draft informed consents.
• Serve as a regulatory consultant and resource person.

Skills

Regulatory Knowledge

Clinical Trials Management

Effective Communication

Decision Making

Education

Bachelor's degree in a related field

Tools

ClinicalTrials.gov

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR II (4) (T224121)

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 multiple levels of research documentation, 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 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. For many, an NCI designation can hold the key to survival. 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.

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

• Maintain regulatory documentation including ICF, protocol, 1572, CV's, ML, IB, recruitment materials, submission forms, draft informed consents.
• Maintain/prepares FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• Serve as a resource person or act as a consultant within area of 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 required. Work experience may substitute for education requirement.

Preferences

• Advanced knowledge in regulatory related to clinical trials and retrospective IRBs.
• Basic knowledge of clinical trials.gov, consenting, and protocol review, adverse and serious adverse event reporting.
• Ability to work independently, to make decisions, to interact with sponsors, regulatory authorities, and investigators.
• Ability to communicate effectively with physicians, sponsors, and other collaborators.

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): Hybrid Eligible