MANAGER-CLINICAL RESEARCH REGULATIONS

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Regulations.

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 oversee regulatory team in larger organizations.
• To manage the preparation and submission of multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To lead the implementation of study specific regulatory processes of a moderate to complex nature.
• To maintain study's compliance with institutional requirements.
• To serve on various committees as appropriate.

Key Duties & Responsibilities

1. Oversees OCCC Quality Assurance team. Assign duties to junior staff.
2. Reviews participant study data/source binders/Informed Consents to ensure compliance with study protocols and related guidelines.
3. Verifies compliance with protocols, Standard Operating Procedures (SOPs), ICH and GCP regulations.
4. Audits data and reports for accuracy and compliance with protocol requirements, SOPs, and GCP regulations.
5. Schedules and performs inspections and audits for assigned work and maintains QA data files.
6. Prepares accurate audit reports and makes recommendations for corrective actions with input/review from Director Quality Management.
7. When applicable, participates in pre-study meetings as QA representative.
8. Assists with follow-up on sponsor and regulatory concerns. Implements QA processes.
9. Responsible for Quality Management and preparation of study related material for FDA and Sponsor audit with assistance as necessary.
10. Ensures proper correction of any queries or issues noted in research data.
11. Identifies needed training programs for clinical research staff based upon quality assurance review and reports. Including but not limited to ALCOA, source documentation completion, and overall QA process training.
12. Evaluates and presents QA findings/metrics to appropriate staff members and managers.
13. Answers inquiries from operations staff when protocol or study-related questions arise.
14. Escalates and presents major findings to the Director of Quality Management.
15. Performs other duties as assigned.

Annual Salary Range: $77,640 - $126,170

Qualifications

Bachelor's degree in a related field and eight (8) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred.

Preferences

• Master's degree preferred.
• 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 execute workload with minimal supervision.

UAB is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse, equitable, and family-friendly environment in which all faculty and staff can excel and achieve work/life balance irrespective of race, national origin, age, genetic or family medical history, gender, faith, gender identity and expression as well as sexual orientation. UAB also encourages applications from individuals with disabilities and veterans.