CLINICAL RESEARCH REGULATORY COORDINATOR II

University of Alabama at Birmingham

United States

July 11, 2021

Description

CLINICAL RESEARCH REGULATORY COORDINATOR II - (T187190)

Description

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.

Position Summary: 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, CV's, ML, IB, recruitment materials, submission forms, draft informed consents. Maintain/prepare FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To serve as resource person or act as consultant within area of regulatory expertise.

Perform other duties as assigned.

(Annual Salary Range: $47,486.40 - $74,484.80)

Qualifications

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

Preferred Education/Skills/Education: 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.

Primary Location

: University

Job Category

: Clinical Research

Organization

: 310008400 Comprehensive Cancer Center

Employee Status

: Regular

Shift: Day/1st Shift