Oncology Clinical Trials Quality Assurance Specialist
2 weeks ago
Oncology Clinical Trials Quality Assurance Coordinator
Required Qualifications: (as evidenced by an attached resume)
A Bachelor's degree in business, science, or a related discipline (foreign equivalent or higher). A minimum of two (2) years of full-time direct experience in Quality Assurance for human research, including at least one (1) year of full-time direct experience with therapeutic trials. Familiarity with IRB regulatory processes, including state and federal guidelines. Proven experience with clinical research review and approval processes.
Preferred Qualifications:
Quality assurance experience specifically in Oncology. Proficiency in using electronic medical records systems (EMR). Experience with Clinical Trials Management Systems (CTMS). Knowledge of Investigator-Initiated Trials (IITs). Proficient in Microsoft Word, Excel, and PowerPoint.
Overview of Responsibilities:
At Stony Brook University, the Quality Assurance (QA) Coordinator plays a crucial role in providing Quality Assurance support for cancer-related research trials managed by the Cancer Clinical Trials Office. Ideal candidates will exhibit exceptional analytical and organizational capabilities, alongside outstanding written and verbal communication skills, while upholding our commitment to excellence. The QA Coordinator should be capable of working autonomously as well as collaboratively within a team, managing multiple research trials, prioritizing tasks, taking initiative, and maintaining a high level of professionalism.
Key Responsibilities:
- Prepare for, participate in, and conduct internal and external audits (e.g., FDA, industry) of cancer center research trials, reporting findings to the QA Manager.
- Assist in the preparation and submission of documentation required for pre and post external inspections (e.g., routine monitoring reports for all studies), including the development and execution of Corrective Action Plans for continuous improvement initiatives.
- Act as a resource for Principal Investigators, staff, and other departments regarding audit procedures, including educating on audit findings and best practices.
- Review internal databases to ensure data entry accuracy and completeness (e.g., Oncore, Florence, RedCap).
- Provide backup support for auditing Investigator-Initiated Trials, including multi-site trials overseen by the Data Safety & Monitoring Committee (DSMC).
- Assist with training and onboarding processes for new investigators and research personnel.
- Support revisions and improvements of Standard Operating Procedures (SOP) and Work Instructions, contributing to strategic planning and implementation of continuous improvement efforts.
- Assist in conducting Site Initiation Visits (SIVs) and routine monitoring visits for multi-institutional sites and affiliate sites.
- Perform other duties as assigned.
The Research Foundation of SUNY operates as a private educational corporation. Employment is subject to the Research Foundation's policies and procedures, sponsor guidelines, and funding availability. This position is classified as FLSA Exempt and is not eligible for overtime provisions under the FLSA. A minimum salary threshold must be met to maintain FLSA exemption.
For this position, we are unable to sponsor candidates for work visas.
Applicants should include a resume/CV and cover letter with their online application.
Stony Brook University is dedicated to fostering diversity and creating an inclusive environment for learning and working. 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 require a disability-related accommodation, please contact the university's Office of Equity and Access (OEA).
In accordance with the Title II Crime Awareness and Security Act, a copy of our crime statistics can be viewed online.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
SUNY Research Foundation: A Great Place to Work.
The starting salary range for this position is noted below, representing SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Salary: $65,000 - $80,000
To apply, visit
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Stony Brook, New York, United States Stony Brook University Full timeOncology Clinical Trials Quality Assurance CoordinatorRequired Qualifications: (as evidenced by an attached resume)Bachelor's degree in business, science, or a related discipline (foreign equivalent or higher). A minimum of two (2) years of full-time direct experience in Quality Assurance for human research, including at least one (1) year of full-time...
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Stony Brook, New York, United States Stony Brook University Full timeOncology Clinical Trials Quality Assurance CoordinatorRequired Qualifications: (as evidenced by an attached resume)Bachelor's degree in business, science, or a related discipline (foreign equivalent or higher). A minimum of two (2) years of full-time direct experience in Quality Assurance for human research, including at least one (1) year of full-time...
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