Clinical Research Associate – 1+ year Contract
Hourly Rate: $60/ hr++
• 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, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, SOPs and data issues.
• Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
• Onsite Monitoring may also be required
• Minimum of college degree in a relevant discipline.
• Bachelor’s degree in relevant scientific discipline preferred.
• Oncology Experience Highly Preferred
• MUST have experience with data review and patient profile review.
3-5 years in-house in pharma company. Experience in phase 3 global study trials in multifunctional areas.