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Flex Staff - (CCTO)

Full/Part Time: Full Time
Department: 015 - Cancer Institute
Requisition Number: 14-1672628

Job Description:

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.



Operations:

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

Job Qualifications:

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.

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