Cancer Clinical Trials Quality Assurance Manager - 1702864
Stony Brook Cancer Center
State University of New York
This position is a very important role in within the Cancer Centerís Clinical Trials Department. The Quality Assurance Manager evaluates patient charts and regulatory documents for compliance and quality assurance. The ideal candidate will be required to both maintain and develop quality assurance processes and procedures, using working knowledge of ICH/GCP requirements along with an understanding for evaluating studies that are NCI and/or institutional funded.
Duties may include but are not limited to the following:
ē Demonstrates general knowledge of biological principles and scientific methods. Demonstrates knowledge of regulatory requirements (EPA, FDA, IRB, SOPs, GCPs, ICH, etc.) by identifying sources of regulatory information, staying current on all new and existing laws, advising staff on regulatory and quality assurance issues, seeking clarification when needed, and conducting training sessions to inform staff of new guidelines/trends. Through the internal audit process, verifies eligibility for enrollment and verifies source documentation for all case report form (CRF) fields and to ensure proper consent document. Conducts training and education for staff on research compliance, institutional policies, federal guidelines and audit findings. Must be able to exercise judgment and discretion and establish and maintain effective working relationships with others. Ability to work with minimal supervision and function independently on a daily basis.
Required Qualifications: Bachelorís Degree. 5 years of relevant experience working with Clinicial Trials. Must be able to work independently with Minimum supervision on a weekly basis.
Preferred Qualifications: Masterís Degree in Science, related to medicine or medical product development. 1 or more years of experience with each of the following preferred: QA/QC, FDA/other Regulatory agencies guidance and regulations, Industry, management/leadership, Product Development, and Auditing.
Stony Brook University is an Affirmative Action/Equal Opportunity employer. We are committed to the creation of a diverse and inclusive campus climate. We encourage protected veterans, individuals with disabilities, women and minorities to apply.
Apply on-line here