Experienced Study Start-Up Coordinator
Core
Prepare, review, and file initial clinical trial applications to regulatory authorities; prepare and submit responses to queries and amendments; ensure compliance with regulations; maintain the Clinical Trial Management System.
Role type
Regulatory Submissions Coordinator
Builds
Regulatory submissions and essential document packages for drug release
Domain
Clinical Research / Regulatory Affairs
Required skills
Regulatory documentation preparation, Ethics Committee submissions, Regulatory agency submissions, Query response formulation, Clinical Trial Management System maintenance, UK regulatory guidelines knowledge, Microsoft Office proficiency
Preferred skills
Life Sciences degree, CRO/Pharma/Investigative site experience, Independent work, Proactive approach, Attention to detail
Responsibilities
Prepare and file clinical trial applications, Submit responses to regulatory queries, Ensure regulatory compliance, Advise team on regulation changes, Maintain CTMS, Prepare essential documents for drug release