ID: 7067447 (Ref.No. hlj_26334)
Posted: July 2, 2020
Application Deadline: Open Until Filled
Research Compliance Quality Auditor I
- 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, the Research Compliance Quality Auditor I 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.
The Ideal Candidate:
- RN/LPN, Research Coordinator, Research Monitor, or individuals with experience in leading research audits/monitoring preferred.
- 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.
- Supports other QA projects as needed.
Credentials and Qualifications:
- Bachelor’s Degree required - health science, health care, and/or background in a medical profession**in lieu of a Bachelor's degree, an Associates degree plus three (3) additional years of working experience in a research quality and regulatory environment. Experience in leading research auditing or monitoring preferred.
- Minimum of three (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.
- Demonstrated ability to independently review databases, trial master files, investigator sites, statistical/clinical study reports, and processes/systems. Ability to conduct computer system validation audits/reviews.
- Ability to accurately interpret research protocols and validate source documentation in the medical records.
- Demonstrated ability to communicate verbally and in writing at an advanced level.
- Strong organization, problem solving, critical thinking and decision‐making skills.
- Capable of working in a team or independently on multiple projects with limited supervision.
- Ability to develop and present educational programs and/or workshops.
- Ability to investigate and analyze information and to apply investigative methods and negotiating techniques when conducting audits/reviews.
- Detail oriented, accurate and able to solve problems pragmatically and assess risk.
- Master’s Degree health science, health care, and/or background in a medical profession (RN/LPN, Research Coordinator, Research Monitor preferred)
- (RN/LPN, Research Coordinator, Research Monitor, or individuals with experience in leading research audits/monitoring preferred).
- CCRC, CCRP, OCN
Mission To create a Moffitt culture of diversity and inclusion as we strive to contribute to the prevention and cure of cancer. Vision Moffitt Cancer Center is recognized as the model wherein the diversity of our employees and communities is valued and supported as essential components to contributing to the prevention and cure of cancer. The cancer center is an equal opportunity employer. It is the policy of the cancer center to prohibit unlawful discrimination and harassment of any type and to afford equal employment opportunities to workforce members and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, genetic information, veteran’s status or any other characteristic protected by federal, state or local law.