Job Details

Title: Research Compliance Quality Auditor I
Company: Moffitt Cancer Center
Location: Tampa, FL

Research Compliance Quality Auditor I prepares, supports, and conducts, research related audits, including reports and follow-up, to ensure that all studies are conducted and billed in compliance with all applicable regulatory and billing requirements, GCP guidelines, and organizational quality standards. Additionally, may be required to:
conduct special complex reviews for allegations of research/clinical trials noncompliance;
participate in areas of faculty and staff education, communication, and policy development;
recommend and ensure appropriate corrective actions; and
provide written reports of research compliance activities and trends to Officer/Manager.

Responsibilities:

Aids in preparation, scheduling, and in conducting audits of investigator initiated and pharma trials, as well as clinical trial billing audits to ensure compliance with applicable regulations, GCP guidelines, and organizational quality standards.
Facilitates corrective and preventive action (CAPA) plans, audit related correspondence, and memos. Maintains QA tracking logs including tracking of CAPA commitments/completion.
Aids in preparation of written reports of audit findings and recommendations and presents to the appropriate department administrators, management, and others as needed; evaluates the adequacy of management corrective action to improve deficiencies; maintains audit records.
Aids in developing research compliance training content; provides one-on-one and group training to research staff to ensure compliance with federal and state regulations and laws, GCP/CMS/FDA and other external regulatory agencies, and internal research policies and procedures.
Maintains required knowledge of applicable regulations and government, industry and company GCP standards by participating in industry trainings, workshops and discussion groups

Credentials and Experience:

Bachelor’s Degree – field of study: health science, health care, and/or background in a medical profession
in lieu of a Bachelor's degree, an Associates degree plus 3 additional years of working experience in a research quality and regulatory environment. Experience in leading research auditing or monitoring preferred.

Minimum of 3 years working experience in a research quality AND regulatory environment. Experience must include clinical trial conduct, protocol adherence, regulatory submissions, and proficiency with electronic systems used to manage clinical trials data or safety reporting. Oncology and/or hematology research experience preferred.
Thorough knowledge of ICH Guidelines, GCPs, and FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations as they pertain to the conduct of clinical trials, e.g., pharma, medical device, clinical trials billing requirements.

To apply for this position or to learn more, please click "Apply Online" below.

SOCRA Exp: 10/14/2022