Entry Site Activation Coordinator
Core
Support Regulatory Submissions and Study Start-Up teams by preparing documents for ethics and competent authorities, ensuring deadlines, and conducting quality control.
Role type
Entry-level Regulatory Submissions Coordinator
Builds
Regulatory submission packages and study documentation for clinical trials
Domain
Clinical Research / CRO / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
document preparation, quality control, deadline management, regulatory compliance knowledge, Microsoft Office proficiency, attention to detail
Preferred skills
Life Sciences degree, 0-3 years regulatory submissions experience, organizational skills
Technologies
Microsoft Office
Responsibilities
Collect vital documents for ethics submissions, prepare study documents for competent authorities, support managers on deadline adherence, conduct quality control of documents, provide compliance guidance to team members
Seniority
Entry-level, mentored IC