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Moffitt Cancer Center · 1 month ago

RESEARCH COMPLIANCE QUALITY AUDITOR II

Tampa, FL

Full-time

Onsite

Mid, Senior Level

4+ years exp

Moffitt Cancer Center is a renowned institution focused on cancer treatment and research. They are seeking a Research Compliance Quality Auditor II who will lead and conduct audits of clinical research studies to ensure compliance with regulations and guidelines, while also providing recommendations for corrective actions and developing compliance education.

Health Care

Responsibilities

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

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

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

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

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

Supports other QA projects as needed

Qualification

Clinical Practice (GCP)Clinical trial auditingResearch complianceLPN/RN licenseCertified Clinical Research Professional (CCRP)International Council for Harmonisation (ICH)FDA regulationsData analysisTraining developmentCommunication skillsOrganizational skillsProblem-solving skillsCritical thinkingNegotiation techniques

Required

Bachelor's Degree required - Field of study: Health Science, Regulatory Affairs, Research/Health Administration, Public Health, Clinical Research, Biomedical Sciences

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

Licensed Practical Nurse (LPN) or Registered Nurse (RN) required

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

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

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

Proven ability to independently audit databases, trial master files, investigator sites, statistical and clinical study reports, and related processes and systems

Skilled in conducting for-cause audits and computer system validation audits

Ability to accurately interpret research protocols and audit medical records for compliance

Advanced verbal and written communication skills for preparing reports and interacting with stakeholders

Strong organizational, problem-solving, critical thinking, and decision-making abilities

Ability to work independently or collaboratively on multiple projects with minimal supervision

Experience in developing and delivering educational programs and workshops on research compliance

Skilled in investigative methods, data analysis, and negotiation techniques

Capable of managing and assigning Corrective and Preventive Action (CAPA) plans effectively

Adaptable in applying investigative approaches for directed and for-cause audits

Highly detail-oriented, accurate, and pragmatic in problem-solving with strong risk assessment capabilities

Preferred

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

Experience in leading research auditing or monitoring is preferred