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Clinical Research Associate - CRA


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CANDIDATES MUST HAVE:
-3-5 years in-house in pharma company
-Phase 3 global study trials in multi-functional areas.
-Experience in reviewing patient data and patient profiles
-Oncology experience

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.
-Minimum of college degree in a relevant discipline. Bachelor's degree in relevant scientific discipline preferred.

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