Regulatory Coordinator, Cancer Center Clinical Trials Office - 2101132
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 related experience totaling at least four (4) years may be considered. Three (3) years of full-time directly related experience.
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 PRMC and Institutional Review Board (IRB). In addition, the Lead 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 of a Regulatory Coordinator may include the following but are not limited to:
Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC and IRB.
Submits 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.
Responds to all questions from the IRB related to the regulatory aspects of the study.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
Meets with monitors from pharmaceutical companies and represents the Stony Brook Cancer Center Clinical Trials Office during these meetings.
Works closely with the Clinical Trial Study Coordinator, research staff and investigators to assure that all regulatory documents for the research studies are up-to-date.
Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
May provide training and education to other personnel and participate in centralized activities of the department or institution.
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.
Ensures compliance with all federal and local agencies including the FDA and local IRB.
Maintains research practices using Good Clinical Practice (GCP) guidelines, strict patient confidentiality according to HIPAA regulations and applicable law and participates in required training and education programs.
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.
Resume/CV and cover letter should be included with the online application.
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Official Job Title: Clinical Research Associate I
Job Field: Research Professional / Technical
Primary Location: US-NY-Stony Brook
Department/Hiring Area: Cancer Center-The Research Foundation for The State University of New York at Stony Brook
Schedule : Full-time Shift : Day Shift Shift Hours : 9 to 5
Posting Start Date: Jun 2, 2021
Posting End Date: Jul 3, 2021, 3:59:00 AM
Salary: Commensurate with experience
Salary Grade: E99
Appointment Type: Regular
Internal Number: 2101132
About Stony Brook University
FROM ITS BEGINNINGS A HALF-CENTURY AGO, STONY BROOK UNIVERSITY HAS BEEN CHARACTERIZED by innovation, energy and progress, transforming the lives of people who earn degrees, work and make groundbreaking discoveries here. A dramatic trajectory of growth has turned what was once a small teacher preparation college into an internationally recognized research institution that is changing the world.