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Job Description
📋 Description Provide logistical support for clinical study operations from start-up to close-out Develop study documents (protocol, informed consent, training materials, amendments, monitoring plans) Manage contracting, budget, invoicing for vendors and sites Support data management with CRF design and EDC testing Train CROs, vendors, investigators and study coordinators on study requirements Monitor trial progress and provide status updates to stakeholders 🎯 Requirements BA/BS degree in life sciences or related field Minimum 4 years of clinical studies experience (academic, biopharma, diagnostics, or medical device) Experience with clinical EDC systems Familiarity with Trial Master File (TMF) structure Competence in SOPs, ICH-GCP, FDA Regulations Proficiency in MS Word, Excel, PowerPoint 🎁 Benefits Comprehensive medical, dental, vision, life and disability plans Fertility care benefits for employees and families Pregnancy and baby bonding leave 401k retirement plan with company match Commuter benefits and employee referral program
