Regulatory and Site Start Up Specialist
Core
Ensure site activation readiness and manage regulatory submissions for clinical trials in oncology and rare diseases.
Role type
Regulatory and Site Start Up Specialist
Builds
Clinical trial sites and regulatory approvals
Domain
Clinical Research / Oncology / Rare Diseases
Deliverable
client delivery
Required skills
Regulatory submission preparation, Competent Authority interaction, Ethics Committee management, site activation planning, document translation coordination, contract negotiation support, feasibility assessment, audit readiness maintenance
Preferred skills
Pharmacy qualification, Pharmacist work experience
Technologies
Clinical Trial Application Forms, submission dossiers, regulatory intelligence tools, TMF
Responsibilities
Prepare and submit Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees; maintain project trackers and regulatory intelligence tools; customize Patient Information Sheets and Informed Consent Forms; coordinate document translations; support site contract negotiations and feasibility assessments; maintain audit/inspection readiness.
Seniority
Mid-level, hands-on IC
