"CLINICAL RESEARCH REGULATORY COORDINATOR II"

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

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/

Please attach a current resume with this application.

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.

Key Duties & Responsibilities

1. Prepares, submits, and assists with multiple levels of research documentation (i.e. FDA, IRB submissions, educational materials, reports, grant renewal reports, and study forms). Maintains regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. Knowledge of GCP (Good Clinical Practice).
2. Prepares and maintains FDA applications, deviations, and SAE (serious adverse events) documents.
3. Makes and assists in modifying protocols and study documents. Completes and submits safety reports and government documents as needed. Enters protocol-specific data into required institutional systems (IRAP and OnCore).
4. Maintains appropriate licensure for clinicians. Conducts internal quality assurance audits of regulatory files. Oversees maintenance of Delegation of Authority logs. Maintain the study's compliance with institutional requirements.
5. Assists colleagues in identifying efficiencies and improving processes.
6. Serves as a mentor to junior regulatory staff. May train others in various work responsibilities and provide constructive feedback.
7. 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

• Preferred degree: Health Care or related field.
• Knowledge of regulatory processes and ICH-GCP guidelines is involved to ensure studies comply with regulations, ethical guidelines, and policies.
• Experience with preparing FDA, IRB, deviation, and SAE submissions applicable to clinical trials.
• Strong communication and relationship-building skills.
• Prior experience in the clinical trial regulatory environment, interacting with sponsors, regulatory authorities, and investigators.
• Ability to communicate effectively with physicians, sponsors, and other collaborators independently.