<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 I conducts and supports audits of clinical research studies to ensure compliance with regulatory requirements, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines, institutional policies and procedures, and organizational quality standards. The Research Compliance Quality Auditor I may also be required to:</p> <ol> <li> <p>Investigate special or complex allegations of research or clinical trial noncompliance.</p> </li><li> <p>Contribute to faculty and staff education, communication, and policy development.</p> </li><li> <p>Recommend and monitor corrective actions.</p> </li><li> <p>Prepare written reports on compliance activities and trends for the Research Compliance</p> </li></ol> <p>Officer/Program Manager.</p> <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>Participates in developing 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>Provides support for additional research compliance and quality assurance projects as assigned. </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 two (2) 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 three (3) years of experience in a research quality and/or regulatory environment, Including clinical trial conduct, protocol adherence, regulatory submissions, and proficiency with electronic systems for clinical trial data or safety reporting. </li><li>Comprehensive knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, Good Clinical Practice (GCP), Food and Drug Administration's Code of Federal Regulations, and other applicable laws and regulations governing clinical trials, including pharmaceutical and medical device. </li><li>Proven ability to independently review databases, trial master files, investigator sites, statistical/clinical study reports, and related processes/systems; experience conducting computer system validation audits/reviews. </li><li>Skilled in interpreting research protocols and validating source documentation within medical records. </li><li>Advanced verbal and written communication skills. </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 developing and delivering educational programs and workshops. </li><li>Proficient in investigative methods and negotiation techniques for audits and compliance reviews. </li><li>Highly detail-oriented, accurate, and pragmatic in problem-solving with strong risk assessment capabilities. </li></ul> <p>Share:</p>