Description
Role:Provide logistical support for Study Team
Develop, maintain and manage appropriate study documentation
Collect, review and approve regulatory documents from clinical sites
Initiate, maintain and reconcile Trial Master File
Set up and maintain tracking systems and tools and report study metrics to support the clinical study
Coordinate communication of tracking information within Study Team and to sites
Manage and track clinical and non-clinical supplies
Manage and track study-specific payments
Coordinate investigator meeting planning in concert with travel planners, including preparing meeting materials and on-site meeting implementation (as requested)
Develop study related documents in collaboration with the study team
Required Qualifications
Experience Required:
2+ years industry experience in equivalent role, Bachelors degree or equivalent undergraduate degree required (scientific or healthcare discipline preferred)
Working knowledge of international regulatory and ICH GCP guidelines
Performs job duties independently with minimal supervision and guidance
Self-motivated and displays initiative
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