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.
Required : BA/BS degree and at least 3 years of directly related experience or, in lieu of BA/BS degree, a combination of higher education and directly related experience totaling at least 4 years will be considered.
Special Notes : Resume/CV and cover letter should be included with the online application.
Posting Overview : This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
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 maybe 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.
This function/position maybe 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.
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*
Complete electronic reference check with a minimum of three (3) professional references.
Successfully complete a 5 panel drug screen*
Successfully complete a Background Check investigation.
Provide a copy of any required New York State license(s)/certificate(s).
Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.
*The hiring department will be responsible for any fee incurred for examination .
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 at (631)632-6280.
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Official Job Title: TH Instructional Support Associate
Job Field: Administrative & Professional (non-Clinical)
Primary Location: US-NY-Stony Brook
Department/Hiring Area: Clinical Trials - Cancer Center-Stony Brook University Hospital
Schedule: Full-time Shift: Day Shift Shift Hours: 9:00 AM - 5:00 PM Pass Days: Sat, Sun
Posting Start Date: Aug 26, 2020
Posting End Date: Nov 25, 2020, 4:59:00 AM
Salary: Commensurate with experience
Salary Grade: SL2
Internal Number: 2002087
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.