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Regulatory Compliance Coordinator
Full/Part Time: Full Time
Location/Affiliates: Mount Sinai Medical Center (Manhattan)
Department: 015 - Cancer Institute
Requisition Number: 13-1541534
The Regulatory Affairs Coordinator ensures compliance with all regulatory, institutional and departmental policies and standards. Meets regulatory and administrative requirements of assigned clinical trials from initial approval to termination; interacts with physicians, research coordinators, and other clinical and administrative staff in the regulatory management of pharmaceutical company, National Cancer Institute (NCI), cooperative group, or internally sponsored clinical trials. Mentors, educates and trains new coordinators in regulatory duties.
1. Prepares and processes applications for Institutional Review Board (IRB) review
Assists the Principal Investigator (PI) in the completion of applications, including all required Grants and Contracts Office (GCO), Protocol Review and Monitoring Committee (PRMC) and IRB paperwork, for approval of new clinical research trials, protocol revisions, and annual renewals.
Coordinates distribution of applications to investigators, pharmacy, division, and department for appropriate sign-off.
Submits applications in a timely manner; responds to comments, questions, and requests for clarification post IRB review by stated deadlines.
Composes informed consent forms and translates complex medical terminology into low-grade reading level.
2. Obtains and maintains required regulatory documentation for all active studies
Assists research coordinators with regulatory documentation requirements and ensures proper regulatory compliance in accordance with sponsoring agency requirements (FDA Form 1572, Financial Disclosure Forms, Investigator licenses, etc).
Prepares serious adverse event and IND safety reports for submission to the IRB
Participates in Study Initiation Visits and Interim Monitoring Visits; prepares documentation for and troubleshoots during cooperative group, FDA, and other regulatory agency audits.
Coordinates all regulatory aspects of investigator initiated multi-site studies
3 Performs other job related duties as required
Maintains and updates Oncology CTO research database and regulatory files
Prepares additional applications as required (GCRC, Radiology Research Application, FDA IND Applications, etc)
Mentors and trains new Regulatory Research Coordinators
Attends divisional/departmental/institutional educational and training seminars
Bachelors Degree in Science related field or English/Writing
A minimum of 5 years of related experience to include at least 6 months experience as a Regulatory Coordinator, Clinical Research Coordinator, Data Manager, or similar role in clinical research.
* Excellent writing skills.
* Ability to understand and interpret complex medical terminology and translate into easy to read language.
* Working knowledge Good Clinical Practice guidelines and Federal research regulations. Demonstrate strong organizational and communication skills.
* Oncology experience preferred.
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.