Reena Patel Email & Phone Number

• Assist Clinical Program Manager in reviewing and finalizing the amendments of study protocols, CRF Guidelines, other study-specific documents, and provide training of these items to Principle Investigators and Study Coordinators.• Work closely with Clinical Program Manager and other Cross-Functional teams in the production of clinical study reports, including appendices development, narrative writing, and review of documents.• Review data tables and listings for multiple sites and data points.• Assist Clinical Program Manager with management of Contract Monitors.• Assist Clinical Program Manager with site management including but not limited to, Site Issue Resolution, DCF Resolution, SAE Query Resolution, and providing both clinical and non-clinical study supplies.• Review monitoring visit reports and work with Contract Monitors in addressing/resolving post visit action items as needed.• Developed and implemented a glossary of terms for Contract Monitors to use while writing monitoring visit reports.• Co-monitor sites and evaluate patient charts for possible SAEs, protocol deviations, inconsistencies with the CRFs, drug accountability and returns. • Review Authorization to Ship Investigational Product (AST IP) prior to approving site activation and study drug shipment to clinical sites.• Manage Monitoring Action Item Tracker, Trip Planner, Site Visit Calendar, and Monitoring Prep Materials to ensure monitoring visit compliance and timelines.• Manage Investigator accruals and payments and ensure that the payments are sent in a timely manner.• Responsible for the management of patient visit tracking, patient reimbursement, and drug re- supply.• Manage the collection, review, tracking and submission of central TMF.• Conduct audits of internal central TMF to ensure files are audit ready. • Author quarterly newsletters for sites.

Listed skills include Cell Culture, Sop, Ich Gcp, Protocol, and 4 others.

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  Rutgers, The State University Of New Jersey-New Brunswick

  Biochemistry