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Clinical Research Associate - CRA - (Yonkers, NY)

APPLICANTS MUST HAVE: -3-five years in-house in pharma company -Phase three global study trials in multi-functional areas. -Background in reviewing patient data and patient profiles -Oncology background SUMMARY: -Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. -Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.). -Participate in development of protocol, case report form, CRF guidelines and other study documents. -Prepare and/or review regulatory documents (e.g. ICF), contracts, and requests for proposal. -Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues. -Reviews and approves monitoring reports and ensures tracking of ongoing site issues.


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Posted in Yonkers, NY, Science & Research
From Get It, LLC - 1 month ago