Description
Job Functions:- Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (up to 40% travel) for GCP
- Recruit investigators for participation in clinical trials
- Conduct project feasibility assessments
- Negotiate study budgets with investigators
- Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
- Review draft protocols for completeness and feasibility
- Develop Case Report Forms for clinical trials
- Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings
- Prepare and process Serious Adverse Event (SAE) reports, according to plan
- Prepare project management reports for clients, project personnel, and PharmaNet management
- Resolve queries of CRF data with study site personnel
- Review tables and listings generated from study data
- Assist in writing clinical study reports
- Train junior CRAs on monitoring, internal procedures, and query resolution
Requirements:
- Bachelors degree in a scientific discipline or RN
- 3+ yearsmonitoring experience
- Clinical trial experience with medical device or diagnostics
- Working knowledge of ICH GCP guidelines
- International clinical trial experience, preferred
To find out more about Real please visit www.realstaffing.com