Description
Primary Responsibilities:- Coordinate and supervise all aspects of a clinical study
- Monitor clinical trial sites
- Assist Clinical Program Manager in overall study management
- Draft and coordinate review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
- Manage CRO/ vendors
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements
Requirements:
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- 6+ years of relevant clinical experience
- BS in scientific discipline
- Must have a general, functional expertise to support SOP development and implementation
To find out more about Real please visit www.realstaffing.com