Regulatory Coordinator, Cancer Center Clinical Trials Office

Required Qualifications (as evidenced by an attached resume):
Bachelor's degree (foreign equivalent or higher). In lieu of a bachelor's degree, a combination of higher education and full-time clinical related experience totaling at least four (4) years may be considered. Three (3) years of full-time directly related clinical trials experience.

Preferred Qualifications:
Experience with Oncology and Phase I trials. Previous use of E-regulatory system and Clinical Trial Management Systems. Experience with WCG, Advarra and NCIRB.

Brief Description of Duties:
The Regulatory Coordinator for the Stony Brook Cancer Center Clinical Trials Department is responsible for all aspects involving the regulatory requirements for studies and clinical trials. The Regulatory Coordinator will be preparing and submitting protocols and supporting documents to regulatory bodies such as Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB). In addition, The Regulatory Coordinator can be called upon to represent the Cancer Clinical Trials office (CCTO) when meeting with pharmaceutical companies, they will attend team meetings, work with other staff to insure all regulatory documents and requirements are met and up-to-date, provide strategies for improving efficiency, action plans and plans to improve quality; provide training and education of personnel as well as ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB.

Duties:

• Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC and IRB, including submission of continuations and amendments, as necessary to maintain compliance with regulatory requirements and institutional policies.
  Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Attends research team meetings and updates staff and investigators on the status of regulatory submission and studies in startup.
• Works with Quality Assurance team to prepare for internal and external audits. May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs, including identifying quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Responds to all questions from the IRB related to the regulatory aspects of the study.
• Meets with monitors from pharmaceutical companies and represents the Stony Brook Cancer Center Clinical Trials Office during these meetings.
• 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.

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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.