Description
Main Responsibilities:- Primary interface with CRO
- Manages communications between monitors and clinical sites and CRO
- Implements and executes clinical programs, including development and administration of site and vendor budgets
- Coordinates with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals, and resources
- Assists in the writing of protocols, the design of case report forms and other study documents and forms
- Works closely with external service vendors to oversee all aspects of clinical trials
- Evaluates, tabulates and may prepare written summaries of clinical data
- Ensures compliance with protocol, overall clinical objectives and FDA/ICH requirements
- Conducts review and source verification of clinical data and ensures timely resolution of data queries
- Maintains contact with clinical investigators and staff
- Tracks all required site documentation
The position requires a BS, (MS preferred) or equivalent in life sciences, or related technical degree with 8+ years of experience. Experience managing multi-site trials, CROs and other vendors required. Thorough knowledge of GCP/ICH requirements needed.
To find out more about Real please visit www.realstaffing.com