The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator II. This position will work under the Director of Quality Management. Responsible for the review of data from clinical trial initiation throughout the trial's duration. Will assist in assuring compliance with the O'Neal Comprehensive Cancer Center standards and all applicable regulations with a strong emphasis on regulatory compliance. The Quality Management department is responsible for reviewing study data, medical records, case report forms, monitoring letters, drug accountability, and regulatory files. It oversees QA compliance with study protocols and ensures study guidelines are followed in accordance with Good Clinical Practices. Emphasis on regulatory documents.

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. Audit Investigator Initiated Trials (IIT), Cooperative trials and pharmaceutical sponsored trials.
2. Conduct internal quality assurance audits of regulatory files.
3. Assist in the design and implementation of quality initiatives ensuring effective and efficient clinical processes.
4. Verify compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH and GCP regulations.
5. Maintains QA data files.
6. Prepares accurate audit reports, makes recommendations for corrective actions with input/review from Director Quality Management.
7. Assists with follow-up on sponsor and internal audit queries. Including assisting with the writing of Corrective and Preventive Actions (CAPA) when applicable.
8. Escalate and present major findings to the Director of Quality Management.
9. Identify needed training programs for clinical research staff based upon quality assurance reviews and reports. Including but not limited to ALCOA, source documentation completion, and overall QA process training.
10. Responsible for Quality Management and preparation of study-related material for FDA, EMA, and Sponsor audits with assistance as necessary.
11. When applicable participate in pre-study meetings as QA representative Evaluate and present Quality Assurance findings/metrics to appropriate staff members and managers.
12. Performs other duties as assigned.

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

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

Preferences

• Knowledge of ICH-GCP guidelines.
• Accuracy, thoroughness, and attention to detail are imperative.
• Skilled in maintaining/reviewing records.
• Skilled in developing and maintaining effective working relationships with staff.
• Ability to work independently as well as within a team.
• Ability to communicate effectively with peers, physicians, and management both orally and in written form.
• Must be self-directed/self-motivated.
• Skill in time management and executing workload with minimal supervision.