Quality Management Coordinator

Position Summary:
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/
This position will work under the Director of Quality Management. Responsible for the review 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. The Quality Management department is responsible for reviewing study data, medical records, case report forms, monitoring letters, drug accountability, and regulatory files. Responsible for the maintenance, and support of Quality Management functions review of study participant research data. Oversees QA compliance with study protocols and ensures study guidelines are followed in accordance with Good Clinical Practices.
Duties and Responsibilities:

• Review assigned study participant study data/source binders/Informed Consents to ensure compliance with study protocols and related guidelines.
• Verify compliance with protocols, Standard Operating Procedures (SOPs), ICH and GCP regulations.
• Audits data and reports for accuracy and compliance with protocol requirements, Standard Operating Procedures, and GCP regulations.
• Schedules and performs inspections and audits for assigned work and maintains QA data files.
• Prepares accurate audit reports, makes recommendations for corrective actions with input/review from Director Quality Management.
• Implement Quality Assurance processes.
• When applicable participates in pre-study meetings as QA representative.
• Assists with follow-up on sponsor and regulatory concerns.
• Responsible for Quality Management and preparation of study related material for FDA Sponsor audit with assistance as necessary.
• Ensure proper correction of any queries or issues noted in research data.
• Identify 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.
• Evaluate and present Quality Assurance findings/metrics to appropriate staff members and managers.
• Answer inquiries from Operations staff when protocol or study-related questions arise.
• Escalate and present major findings to the Director of Quality Management.
• Perform other duties as assigned

Salary Range: $47,665- $77,455
Qualifications
Associate's degree in a related field and two (2) years of related experience required. Work experience may NOT substitute for education requirement. Bachelor's degree preferred. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
Preferred Qualifications:

• Knowledge of ICH-GCP guidelines. Accuracy, thoroughness and attention to detail imperative.
• Skill in maintaining / reviewing records.
• Skill 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.