Description
Responsibilities: 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 teamSkills: Perform 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 - Experience updating / managing cTMF required
Education: 2+ years industry experience in equivalent role - Bachelors degree required (scientific or healthcare discipline preferred) - Working knowledge of international regulatory and ICH GCP guidelines
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