CLINICAL RESEARCH REGULATORY COORDINATOR II (2)

University of Alabama at Birmingham; Birmingham (AL); On-site; USD 48,000 - 77,000; Full time

Job summary

University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II to prepare, submit, and manage regulatory documentation for IRB submissions, INDs, and IDEs. This role entails maintaining consent forms, protocols, CVs, licenses, recruitment materials, safety reports, and submission forms.

Responsibilities include drafting informed consents, preparing FDA applications for INDs/IDEs, and providing regulatory guidance to the team.

Qualifications

• Bachelor's degree in a related field and three (3) years of related experience required.
• Work experience may substitute for education requirement.

Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation (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 area of regulatory expertise.

Skills

Regulatory knowledge

IRB submissions

IND/IDE familiarity

Communication

Education

Bachelor's degree

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR II (2) (T238047)

CLINICAL RESEARCH REGULATORY COORDINATOR II (2) - ( T238047 )

Description

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

The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of research documentation, IRB submissions to UAB, WIRB, Advarra, and others. Maintain regulatory documentation, including ICF, protocol, 1572, CVs, ML, IB, recruitment materials, submission forms, and draft informed consents. Maintain/prepare FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To serve as a resource person or act as a consultant within the area of regulatory expertise.

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. 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. The link to our website is: https://www.uab.edu/onealcancercenter/

General Responsibilities

To prepare, submit, and assist with multiple levels of research documentation (i.e., IRB submissions, educational materials, reports, grant renewal reports, and study forms).

To maintain regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.

To draft informed consents.

To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).

To assist in drafting compliant advertisements.

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

Performs 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 matters 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, 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, 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.

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