"CLINICAL RESEARCH QUALITY COORDINATOR"

Job Description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Quality Coordinator. This position will work under the Director of Quality Management. To contribute to the safety and quality of patients participating in clinical trials conducted at the OCCC, the Quality Management staff are responsible for reviewing patient data from the patient's clinical trial initiation to the last clinical trial visit. During this time, the candidate must function as a resource to the faculty and staff. These positions are unique in that candidates must have prior knowledge of clinical research coordination, data management, regulatory practices, and the writing of CAPA. The candidate must be knowledgeable in Good Clinical Practices, including but not limited to Federal, state, local, and OCCC regulations. The Quality Management department is responsible for reviewing study data, medical records, case report forms, monitoring letters, Adverse events, serious adverse events, drug accountability, and regulatory files.

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/

General Responsibilities

• To ensure the quality and regulatory compliance of clinical research activities assigned to studies or programs.
• To support the monitoring and auditing of quality assurance processes and provide guidance to research teams to ensure adherence to institutional and federal requirements.

Key Duties & Responsibilities

• Serves as the primary in-house site monitor for oncology clinical trials of various complexities.
• Monitors investigator-initiated trials, multi-center trials, and cooperative trials for quality assurance.
• Conducts monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of CRFs, source documents, medical records, and regulatory documents.
• Verify compliance with protocols, Standard Operating Procedures (SOPs), ICH, and GCP regulations.
• Assists in ensuring audit-ready files; contributes to company, client, and federal/local regulatory requirements/audit responses, as needed.
• Prepares accurate audit reports, makes recommendations for corrective actions with input/review from the Director of Quality Management.
• When applicable, participates in pre-study meetings as QA representative.
• Ensures proper correction of any queries or issues noted in research data.
• Evaluates and presents Quality Assurance findings/metrics to appropriate staff members and managers.
• Issues and reviews Corrective Action and Preventative Action plans (CAPA) in cases of noncompliance.
• Answers inquiries from Operations staff when protocol or study-related questions arise.
• Escalates and presents major findings to the Director of Quality Management.
• Provides feedback to assist sites, which includes a summary of overall site functioning and detected deficiencies, and corrective action needed, and follows up with sites until deficiencies are resolved.
• Attends internal meetings, training opportunities.
• Performs 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

• Prior experience in the clinical trial environment.
• Knowledge of ICH-GCP guidelines.
• Previous working experience with Corrective and Preventive Action Plans (CAPAs).
• Accuracy, thoroughness, and attention to detail are 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.
• Ability to effectively teach and educate fellow staff and faculty.
• Must be self-directed / initiative-taking.
• Skill in time management and executing workload with minimal supervision.

About University of Alabama, Birmingham

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with more than $715 million in annual research funding and an economic impact on the state exceeding $12.1 billion a year. UAB is Alabama’s largest employer, with some 28,000 employees, and was named Forbes’ No. 1 Large Employer in the United States in 2021. UAB enrollment surpassed 21,500 for the fifth consecutive year in fall 2022. The university offers more than 180 degree programs in nine schools and one college. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement and patient care. Learn more at www.uab.edu.