Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
Job Summary
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Matching Summary
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Skills & Requirements
Must-have
Trial Master File (TMF) maintenance
Clinical documentation handling
Tracking clinical data flow
Project communications management
Microsoft Word, Excel, PowerPoint
Nice-to-have
Effective time management
Organizational skills
Establish working relationships
Awareness of GCP and ICH guidelines
Key Requirements
High School Diploma or equivalent
3 years administrative support experience
Equivalent combination of education, training and experience