Job Abstract

Required Qualification: (as evidenced by an attached resume)
Bachelor's degree in business, science or related field (foreign equivalent or higher). Two (2) years of full time direct experience in Quality Assurance for human research, including one (1) year of full time direct experience with therapeutic trials. Experience with IRB Regulatory processes including state and federal guidelines. Experience with processes for clinical research review and approval.

Preferred Qualification:
Quality assurance experience in Oncology. Experience using electronic medical records system (EMR). Experience using Clinical Trials Management System (CTMS). Experience with Investigator-Initiated Trials (IITs). Proficiency with Microsoft Word, Excel and PowerPoint.

Brief Description of Duties:
At Stony Brook Medicine, a Quality Assurance (QA) Coordinator is a valuable member of our team who provides Quality Assurance support to cancer related research trials that are overseen by the Cancer Clinical Trials Office. Qualified candidates will demonstrate superior analytical and organizational skills and possess outstanding written and communication skills while adhering to our high standard of excellence. The QA Coordinator will have the ability to work independently and as part of a team with minimal supervision and must be able to manage multiple research trials, prioritize, take initiative and maintain a high level of professionalism.

Duties:

• Prepare, participate and conduct internal and external audits (e.g. FDA, industry) of cancer center research trials conducted by the Cancer Clinical Trials staff including reporting findings to QA Manager.
• Assist in documentation preparation and submission as required from pre and post external inspections (e.g. routine monitoring reports for all studies), including preparing and executing Corrective Action Plans for continuous improvement efforts.
• Serve as a resource for PI's, Staff and other departments relating to audit conduct, including education on audit findings and best practices.
• Review internal databases for data entry accuracy and completeness (e.g. Oncore, Florence, RedCap).
• Provide backup support auditing for Investigator Initiated Trials, including multi-site trials overseen by the Data Safety & Monitoring Committee (DSMC).
• Assist with training and onboarding for new investigators and research staff.
• Assist with SOP and Work instruction revisions & improvements, including assisting with strategic planning and implementation of continuous improvement efforts.
• Assist with conducting SIVs routine monitoring visiting for multi-institutional sites and monitoring for affiliate sites.
• Other duties as assigned.

Special Notes:
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.

For this position, we are unable to sponsor candidates for work visas.

Resume/CV and cover letter should be included with the online application.

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.

If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA.

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The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU’s good faith and reasonable estimate of the range of possible compensation at the time of posting.