Description
Primary Responsibilities:- Provide logistical support for clinical study teams
- Develop, maintain and manage clinical study documentation
- Collect, review and manage regulatory documents from clinical sites
- Responsible for setup and maintenance of Trial Master File (TMF); assists with reconciliation of the TMF
- Prepare and distribute meeting agendas and status reports; compiles and distributes study materials to the CRO; acts as an in-house resource for the study team
- Manage and track clinical and non-clinical supplies
- Manage, track, verify study-specific invoices
- Coordinate investigator meeting planning in concert with travel planners, including preparing meeting materials and on-site meeting implementation
Skills & Experience Required:
- 2+ years clinical research industry experience
- Working knowledge of international regulatory and ICH GCP guidelines
- Performs job duties independently with minimal supervision and guidance
- Highly effective verbal and written communication skills in English
- Effectively collaborates with team members
- Proven organizational skills demonstrated by the ability to understand and prioritize instructions and deliver on time
- Experience using computer applications including spreadsheets, email, word-processing software & web-based systems
To find out more about Real please visit www.realstaffing.com