Description
Duties: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 These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.
Skills:
- 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 - Attention to details Other: In-house, 40 hours/week, minimal (if any) travel required.
Education:
- 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
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