Regulatory and Start Up Specialist - Romania
Core
Country-level specialist managing site activation and regulatory compliance for clinical research studies in Romania.
Role type
Senior IC Regulatory and Start Up Specialist
Builds
Clinical research studies for life sciences and healthcare clients
Domain
Clinical research / Life sciences
Required skills
Romanian language proficiency, site activation execution, regulatory document preparation, SOP adherence, internal system maintenance, project timeline management, quality control of site documents
Preferred skills
Experience with Investigator Pack (IP) and Informed Consent Form (ICF) release, contingency planning, direct sponsor contact
Technologies
Internal systems, databases, tracking tools
Responsibilities
Serve as Single Point of Contact (SPOC) for investigative sites; prepare and review site regulatory documents for completeness and accuracy; track and follow up on approval and execution of regulatory and ethics documents; ensure accurate completion of internal systems and databases; provide local expertise to Site Activation Managers (SAMs) and project teams; perform quality control of documents provided by sites.
Seniority
Mid-level, hands-on IC
