Regulatory Affairs Study Start Up Specialist II
Core
Assist project teams with regulatory requirements, compliance assessments, and documentation for clinical studies across multiple countries.
Role type
Regulatory Affairs Study Start Up Specialist
Builds
Regulatory submission packages, study start-up checklists, and compliant clinical trial documentation.
Domain
Clinical Research / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory compliance assessment, IRB/EC/CA submissions, document review and QC, ICF adaptation, Clinical Trial Application preparation, deficiency letter response, translation oversight, audit preparation, TMF management, contract management
Preferred skills
Knowledge of ICH/GCP guidelines, experience with CRO SOPs
Technologies
TMF systems, study start-up modules, trackers
Responsibilities
Perform compliance assessments and notify project managers of findings; Review and adapt study documents per country/site requirements; Process and QC study documentation from sites; Interact with site personnel and project managers for document resolution; Compile regulatory documentation and perform QC before submission; Respond to deficiency letters from regulatory bodies; Manage site budgets and contracts depending on region.
Seniority
Mid-level, hands-on IC
