CLINICAL RESEARCH REGULATORY COORDINATOR II (2)

About the Role

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.

About the O'Neal Comprehensive Cancer Center

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.

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 resource person or act as consultant within area of regulatory expertise
• Perform other duties as assigned

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

Pay

Annual Salary Range: $47,665 - $77,455