Clinical Research Associate – NJ
1-3 year Contract
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
Bachelor’s Degree in relevant scientific discipline preferred. 3-5 years in-house in pharma company. Experience in phase 3 global study trials in multifunctional areas. Must have experience in reviewing patient data and patient profiles. **Oncology Experience Highly Preferred