Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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 monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Skills & Requirements
Must-have
Perform site monitoring visits
Ensure protocol adherence
Manage study progress
Maintain site documentation
Good Clinical Practice (GCP)
Nice-to-have
Enhance predictability
Collaborate with study teams
Adapt recruitment plans
Key Requirements
At least 2 years of on-site monitoring experience
High School Diploma or equivalent
Good knowledge of regulatory requirements (GCP, ICH)