This position is a very important role in within the Cancer Center's 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:
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.
Creates and implements a quality assurance program to provide internal auditing of oncology research trials conducted at Stony Brook Cancer Center. This plan will include monitoring of essential documents and research activities to ensure compliance with institutional, FDA, and OHRP policies and regulations and Good Clinical Practice Guidelines. Reviews and continually assesses the internal audit process, establishing targeted and routine review of all active enrolling trials at the Center and NCI Community Oncology Research Program component sites. Travel to NCORP sites will be required and include auditing and training with physicians and research staff. Develops standard operating procedures to guide the quality assurance program,. Creates reporting tools to capture findings for both Essential Documents and Patient Cases. Functions as consultant to research team and investigators to provide training on management and conduct of research studies. Overall goal is to ensure compliance with federal, state, and institutional policies and Good Clinical Practice Guidelines. Participates and assists with preparation for routine audit visits. Responsible for writing audit response letters and developing corrective action plans. In addition, reviews all studies for compliance and implements and monitors corrective action plan(s) as needed. Responsible for ongoing review of common audit findings to completion of root cause analysis of common deficiencies. Prepares presentations to or reports to communicate summary findings and recommendations to Stony Brook Cancer Center administration.
Serves as Auditor on the Data Safety Monitoring Committee (DSMC) and is responsible for monitoring and evaluating the Investigator Initiated Oncology Trials conducted within the Stony Brook Cancer Center. Reviews Food and Drug Administration applications made on behalf of University sponsor-investigators for accuracy and compliance to Federal Code of Regulations and identifies and report deficiencies to the principal investigator, study team and DSMC. Develops audit report findings and presents at DSMC meetings. Oversees the scheduling and training of audits and maintains the Clinical Trials Management System for tracking audit activities. Functions autonomously with a high level of attention to detail. Establishes and maintains effective working relationships with physicians, study coordinators and data managers. Identify, develop and implement processes and procedures to streamline efficiencies. Performs as an effective communicator as demonstrated by verbal and written communication.
Required Qualifications: Bachelor's 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: Master's 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.
Special Notes: Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises. All Hospital positions are subject to changes in pass days and shifts as necessary. This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
The selected candidate must successfully clear a background investigation. Prior to start date, the selected candidate must meet the following requirements: Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services (The hiring department will be responsible for any fee incurred for examination), submit (3) written references, and provide a copy of any required New York State license(s)/certificate(s). Please be advised that failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.
The best ideas in medicine start with the best people. At Stony Brook Medicine, our highest calling is to put the power of ideas to work in our patients' lives. Stony Brook Medicine integrates and elevates all of our health-related initiatives: education, research and patient care.Stony Brook Medicine is Long Island's premier academic medical center. With 603 beds, we serve as the region's only tertiary care center and Level 1 Trauma Center, and are home to the Stony Brook Heart Institute, Stony Brook Cancer Center, Stony Brook Children's Hospital, Stony Brook Neurosciences Institute, and Stony Brook Digestive Disorders Institute. We also encompass Suffolk County's only Level 4 Regional Perinatal Center, state-designated AIDS Center, state-designated Comprehensive Psychiatric Emergency Program, state-designated Burn Center, the Christopher Pendergast ALS Center of Excellence, and Kidney Transplant Center. It is home of the nation's first Pediatric Multiple Sclerosis Center.
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.
This function/position has been designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
Pursuant to Executive Order 161, no State entity, as defined by the Executive Order, is permitted to ask, or mandate, in any form, that an applicant for employment provide his or her current compensation, or any prior compensation history, until such time as the applicant is extended a conditional offer of employment with compensation. If such information has been requested from you before such time, please contact the Governor's Office of Employee Relations at (518) 474-6988 or via email at firstname.lastname@example.org.
IF YOU NEED A DISABILITY-RELATED ACCOMMODATION, PLEASE CALL THE UNIVERSITY HUMAN RESOURCE SERVICES DEPARTMENT AT (631) 632-6161 OR THE UNIVERSITY HOSPITAL HUMAN RESOURCES DEPARTMENT AT (631) 444-4700. IN ACCORDANCE WITH THE TITLE II CRIME AWARENESS AND SECURITY ACT, A COPY OF OUR CRIME STATISTICS IS AVAILABLE UPON REQUEST BY CALLING (631) 632-6350. IT CAN ALSO BE VIEWED ON-LINE AT THE UNIVERSITY POLICE WEBSITE AT http://www.stonybrook.edu/police
Official Job Title: TH Instructional Support Specialist
Job Field: Other
Primary Location: US-NY-Stony Brook
Department/Hiring Area: Cancer Center-Stony Brook University Hospital
Schedule: Full-time Day Shift 9am to 5pm Pass Days: Sat, Sun