Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice
Job Summary
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Matching Summary
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
Skills & Requirements
Must-have
site monitoring visits
subject recruitment plan
protocol and study training
quality and integrity evaluation
study progress management
Trial Master File (TMF) documentation
Investigator's Site File (ISF) maintenance
Nice-to-have
effective time management
effective financial management
establish working relationships
Key Requirements
at least 3 years of on-site monitoring experience
CRA Certification according to Ministerial Decree dated 15.11.2011
Good knowledge of applicable clinical research regulatory requirements
Good therapeutic and protocol knowledge
Computer skills including proficiency in Microsoft Word, Excel and PowerPoint