<p>At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.</p> <p>Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.</p> <p>Summary</p> <p>Position Highlights</p> <p>The Research Compliance Quality Auditor II leads and conducts complex audits of clinical research studies to ensure adherence to federal and state regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines, U.S. Food and Drug Administration (FDA) requirements, institutional policies and procedures, and organizational quality benchmarks. The Research Compliance Quality Auditor II may also be required to:</p> <ol> <li> <p>Identify and assess research compliance risks.</p> </li><li> <p>Investigate special or complex allegations of research/clinical trial noncompliance.</p> </li><li> <p>Provide expert recommendations for corrective and preventive actions.</p> </li><li> <p>Develop and deliver compliance education and contribute to policy development.</p> </li><li> <p>Prepare detailed reports on audit findings and compliance trends for the Research Compliance Officer/Program Manager.</p> </li></ol> <p>The Ideal Candidate:</p> <ul> <li>The ideal candidate will have experience in a research quality and/or auditing environment with expertise, knowledge, and GCP experience in auditing clinical trials, including auditing internal processes, performing sponsor audits and proficiency with electronic systems used to manage clinical trial data or safety reporting. Oncology and/or hematology research experience preferred. </li><li>The ideal candidate will have LPN/RN license. </li></ul> <p>Responsibilities:</p> <ul> <li>Prepares, schedules, and conducts audits of investigator-initiated trials (IITs) and pharmaceutical sponsored trials to ensure compliance with applicable federal and state regulations, Good Clinical Practice (GCP) guidelines, and organizational quality standards. </li><li>Coordinates and manages corrective and preventive action (CAPA) plans to address audit findings and ensure timely resolution of compliance issues. Oversees audit-related correspondence and documentation, including memos and follow-up communications. </li><li>Prepares comprehensive written reports summarizing audit findings and recommendations, and presents results to department administrators, management, and other stakeholders as needed. Evaluates the effectiveness of corrective actions implemented by management to address identified deficiencies. Maintains accurate and organized audit records in accordance with institutional and regulatory requirements. </li><li>Develops research compliance training materials and delivers one-on-one and group training sessions to research and compliance staff. Ensures staff understanding and adherence to federal and state regulations, Good Clinical Practice (GCP) guidelines, U.S. Food and Drug Administration (FDA) regulations, and other applicable external agency standards, as well as internal research policies and procedures. </li><li>Maintains advanced knowledge of federal and state regulations, industry standards, and organizational policies governing clinical research, including Good Clinical Practice (GCP) guidelines, U.S. Food and Drug Administration (FDA) requirements, Centers for Medicare & Medicaid Services (CMS) standards, and other applicable agency regulations. Actively engages in professional development through participation in industry trainings, workshops, conferences, and expert discussion forums to ensure compliance expertise remains current and applicable to institutional needs. </li><li>Supports other QA projects as needed. </li></ul> <p>Credentials and Experience:</p> <ul> <li>Bachelor's Degree required - Field of study: Health Science, Regulatory Affairs, Research/Health Administration, Public Health, Clinical Research, Biomedical Sciences. </li><li>In lieu of a Bachelor's degree, an Associate's degree plus three (3) years of experience in a research quality and/or auditing environment. Experience in leading research auditing or monitoring is preferred. </li><li>Licensed Practical Nurse (LPN) or Registered Nurse (RN) required - </li></ul> <p>In lieu of an LPN or RN license, two (2) years of Good Clinical Practice (GCP) auditing experience and a current Certified Clinical Research Professional (CCRP) certification may be considered.</p> <ul> <li>Minimum of four (4) years of experience in a research quality, regulatory, and/or auditing environment, with demonstrated expertise in Good Clinical Practice (GCP) auditing of clinical trials. Experience should include auditing internal processes, performing sponsor audits, and proficiency with electronic systems used for clinical trial data management and safety reporting. </li><li>Comprehensive knowledge of International Council for Harmonisation (ICH) Guidelines, Good Clinical Practice (GCP) standards, U.S. Food and Drug Administration (FDA) Code of Federal Regulations, and other applicable laws and regulations governing clinical trials, including pharmaceutical and medical device requirements. </li><li>Proven ability to independently audit databases, trial master files, investigator sites, statistical and clinical study reports, and related processes and systems. </li><li>Skilled in conducting for-cause audits and computer system validation audits. </li><li>Ability to accurately interpret research protocols and audit medical records for compliance. </li><li>Advanced verbal and written communication skills for preparing reports and interacting with stakeholders. </li><li>Strong organizational, problem-solving, critical thinking, and decision-making abilities. </li><li>Ability to work independently or collaboratively on multiple projects with minimal supervision. </li><li>Experience in developing and delivering educational programs and workshops on research compliance. </li><li>Skilled in investigative methods, data analysis, and negotiation techniques. </li><li>Capable of managing and assigning Corrective and Preventive Action (CAPA) plans effectively. </li><li>Adaptable in applying investigative approaches for directed and for-cause audits. </li><li>Highly detail-oriented, accurate, and pragmatic in problem-solving with strong risk assessment capabilities. </li></ul> <p>Share:</p>