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, Good Clinical Practice ("GCP") guidelines, and organizational quality standards.
Additionally, may be required to:
o Conduct special complex reviews for allegations of research/clinical trials noncompliance;
o Participates in areas of faculty and staff education, communication, and policy development;
o Identify and assess areas of research compliance risk for Moffitt;
o Recommend and ensure appropriate corrective actions; and
o Provide written reports of research compliance activities and trends to Officer/Manager.
The Ideal Candidate:
Ability to adapt and apply innovative methods and negotiating techniques to conduct audits such as directed or for-cause audits.
Detail oriented, accurate and able to solve problems pragmatically and assess risk.
Prepares, schedules and conducts 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, audits related correspondence, and memos. Maintains QA tracking logs including tracking of CAPA commitments/completion.
Prepares 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.
Develops 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** – health science, health care, and/or background in a medical profession ** In lieu of a Bachelor's Degree, an Associate's Degree plus one (1) year of experience in a research quality and/or auditing environment (for a total of three (3) years of research quality and/or auditing experience)
LPN**In lieu of an LPN license/certification, one (1) year of specific GPC auditing experience may be considered
Two (2) years working 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.
Thorough knowledge of ICH Guidelines, GCP's 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 audit databases, trial master files, investigator sites, statistical/clinical study reports, and processes/systems. Ability to conduct for-cause audits and computer system validation audits.
Ability to accurately interpret research protocols and audit medical records.
RN, Research Coordinator, Research Monitor
CCRC, CCRP, OCN
Internal Number: 27694
About H. Lee Moffitt Cancer Center
H. Lee Moffitt Cancer Center and Research Institute is the only NCI-designated comprehensive cancer center in Florida and is ranked in the top 10 cancer hospitals in the nation by US News and World Report in Adult Cancer. We are shaping the future of cancer care through innovative research, clinical advances, and superior education within an environment that encourages excellence. We educate tomorrow’s most promising oncologists within our wide range of residency and fellowship programs. Our clinical campuses include large ambulatory care facilities, CLIA-certified laboratories, a dedicated cancer hospital, and a wide spectrum of outreach activities consistent with our NCI Comprehensive Cancer Center designation. The Moffitt Research Institute is comprised of approximately 150 Principal Investigators, 58 laboratories, and 306,000 square feet of research space.