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Flex Staff - (CCTO)
Full/Part Time: Full Time
Department: 015 - Cancer Institute
Requisition Number: 14-1672628
Serve as a member of the Cancer Clinical Trials Office Administrative team to provide oversight of the day-to-day operations of research coordinators and clinical trials management.
o Oversight of DAY TO DAY activities of research coordinators & trial management
o Track study enrollment & address barriers with CCTO leadership & DFG
o Maintain master study tracking log for CCTO & TCI DFG metrics reporting
o Participate in sponsor audits & FDA audits when applicable
o Responsible for all aspects of clinical research regulatory compliance, including document preparation, submission and management for a specified portfolio of clinical trials
o To collaborate with the Principal Investigator, Clinical Research Nurse, the Clinical Research coordinator and the Sponsor.
o To prepare and submit documents to both internal and external regulatory authorities
o To organize and maintain for each protocol a Regulatory Binder
o Preparation and Participation in Site Initiations, study monitoring visits and study audits
o To maintain up to date listings of regulatory items, including status of new protocols, amendments and other relevant regulatory issues
B.A or B.S. degree in Administration; Master's degree preferred.
Knowledge of cancer clinical trials
Knowledge of pre-awards
5 years of financial experience
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.