Research Compliance Quality Auditor
Vitaver & Associates, Inc.
Tampa , FL 33612
Posted 1 week ago
11987 - Research Compliance Quality Auditor - Tampa, FLType:
Full-time direct employment with Vitaver Staffing Client.Onsite:
On location at the Clients site 100% of the time. No telecommuting or remote work.Description:
Our Client, a non-profit medical research center, is hiring a Research Compliance Quality Auditor in Tampa, FL.Responsibilities:
Prepare, schedule and conduct 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.
Facilitate corrective and preventive action (CAPA) plans, audits related correspondence, and memos. Maintain QA tracking logs including tracking of CAPA commitments / completion;
Prepare written reports of audit findings and recommendations and present to the appropriate department administrators, management, and others as needed; evaluate the adequacy of management corrective action to improve deficiencies, maintain audit records;
Develop 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;
Maintain required knowledge of applicable regulations and government, industry and company GCP standards by participating in industry trainings, workshops and discussion groups;
Support other QA projects as needed.Requirements:
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 (2+ years). Oncology and/or hematology research experience preferred.
Experience independently auditing databases, trial master files, investigator sites, statistical / clinical study reports, and processes / systems. Ability to conduct for-cause audits and computer system validation audits;
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.
Ability to accurately interpret research protocols and audit medical records;
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;
Bachelor's degree in Health Science, Health Care, and/or background in a medical profession. In lieu of a Bachelor's degree, an Associate's degree plus 1 year of experience in a research quality and/or auditing environment (for a total of 3 years of research quality and/or auditing experience);
LPN license / certification. In lieu of an LPN, 1 year of specific GPC auditing experience may be considered;
RN, Research Coordinator, Research Monitor (preferred);
CCRC, CCRP, OCN (preferred).Why apply?
Work with an organization that made prevention and cure of cancer its goal and gathered best minds and talents to accomplish it;
Secure a career with a healthcare provider with stable history and increasing needs for new talent and employees;
Join a diverse, friendly and result oriented team dedicated to explore and discover newest technologies and methods;
Receive plenty of coaching and support from the supportive and friendly team of Clients employees and other Vitaver consultants working onsite already;
Benefit from multiple projects extensions and an opportunity to apply full time after your contract engagement is successfully completed;
Become eligible for comprehensive benefits package including onsite child care, education assistance and more (for salaried employees);
Move to one of the nicest areas to enjoy great dining, amazing climate, theme parks and attractions, shopping malls and galleries and no personal income tax;
Receive competitive compensation and always get paid in full and on time.If this job is not for you, earn a $2,100.00 referral bonus in cash by referring a Candidate or a Client to us. Vitaver Referral Program is one of the most generous on the market!