Quality Assurance Nurse - Clinical Trials

Position Summary This position is a very important role within the Cancer Center’s Clinical Trials Department. Under the direction of the Quality Assurance Manager, the Quality Assurance Nurse evaluates patient charts and regulatory documents for compliance and quality assurance. The role maintains and develops quality assurance processes and procedures, using a working knowledge of ICH/GCP requirements and evaluating Investigator‑Initiated, NCI, and/or Industry funded studies. Duties Demonstrates general knowledge of biological principles and scientific methods, regulatory knowledge (FDA, IRB, SOPs, GCPs, ICH, etc.), stays current on regulations, advises staff, seeks clarification, and conducts training sessions. Verifies eligibility for enrollment and source documentation for all CRF fields, ensuring proper consent documentation under QA Manager’s direction and through internal audit. Conducts training and education for staff on compliance, policies, guidelines, and audit findings. Serves as an auditor on the Data Safety Monitoring Committee (DSMC) and monitors Investigator‑Initiated Oncology Trials. Works with Investigator‑Initiated Trials staff to review FDA applications for accuracy and regulatory compliance. Participates in preparation for routine audit visits and writes audit response letters, developing CAPA. Prepares presentations or reports for Stony Brook Cancer Center administration. Functions autonomously with a high level of attention to detail. Exercises judgement and discretion to maintain effective working relationships. Assists in documentation preparation and submission for external inspections and corrective action plans. Reviews internal databases for data entry accuracy and completeness (Oncore, Florence, RedCap). Provides training and onboarding for new investigators and research staff. Assists with SOP and work instruction revisions, strategic planning, and continuous improvement. Assists with SIVs routine monitoring visits for multi‑institutional and affiliate sites. Provides backup as a Research Nurse when required. Performs additional duties or audits as assigned. Required Qualifications Bachelor’s Degree in Nursing Current and active NYS RN License At least 5 years of relevant experience in Clinical Trials Works independently with minimal supervision Good communicator Knowledge of computer systems and databases Preferred Qualifications Advanced degree in nursing Experience in Cancer Clinical Trials Experience in a QA/QC clinical trials role Knowledge of regulatory guidance and regulations Experience in Clinical Trials Monitoring/Auditing Additional Requirements Before Start Successful completion of pre‑employment physical examination and medical clearance from Stony Brook Employee Health Services Completion of electronic reference check with at least three professional references Successful completion of a 4‑panel drug screen Meet regulatory requirements for pre‑employment screenings Provide copy of any required New York State license(s)/certificate(s) Benefits and Compensation The starting salary range is $89,760 to $127,975 per year. Additional benefits include generous leave, health plans, and state pension. Position may offer supplemental pay such as location pay ($4,000) for UUP full‑time roles. EEO Statement Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status, and all other protected classes under federal or state laws. #J-18808-Ljbffr Stony Brook Medicine