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
Clinical trial authorizations and site activation readiness
Domain
Life Sciences / Clinical Trials / Oncology / Rare Disease
Required skills
Regulatory submission preparation, Essential document collection, Contract negotiation support, Project plan maintenance, Translation coordination, Site activation readiness management, Local clinical trial law knowledge, TMF management
Preferred skills
Feasibility experience, Milestone tracking tools usage, Workload prioritization, Advanced degree in medical/life sciences, RAC certification, Masters in Regulatory Science
Technologies
Computerized information systems, Electronic spreadsheets, Word processing, Electronic mail, Milestone tracking tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers for CA/EC, Interact with CA/EC for study purposes, Maintain project plans and regulatory intelligence tools, Customize Patient Information Sheets and Informed Consent Forms, Facilitate document translations, Partner with site CRAs for alignment, Support budget negotiation and investigator contracts, Maintain audit/inspection readiness, Support Pre-Study Site Visits, Participate in process improvement and mentoring
Seniority
Mid-level, hands-on IC
