Regulatory and Site Start Up Specialist
Core
Regulatory and Site Start Up Specialist responsible for clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review, Essential Document collection, and supporting sites on contract negotiation.
Role type
Regulatory and Site Start Up Specialist
Builds
Site activation readiness and regulatory approvals for clinical trials
Domain
Life Sciences / Clinical Trials / Oncology / Rare Disease
Required skills
Clinical trial regulations knowledge, IRB/EC submission management, Essential document collection, Contract negotiation support, Project planning, Translation coordination, Site activation readiness, Local law compliance
Preferred skills
Feasibility experience, Milestone tracking tools, Workload prioritization, Advanced degree in medical/life sciences, RAC certification
Technologies
Computerized information systems, Electronic spreadsheets, Word processing, Electronic mail
