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.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
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
Evaluate study site practices
Manage study progress
Maintain Trial Master File
Good Clinical Practice (GCP)
ICH guidelines
Nice-to-have
Enhance predictability
Effective time management
Problem-solving skills
Establish working relationships
Key Requirements
At least 1 year of on-site monitoring experience
Bachelor's Degree in scientific discipline or health care
Proficiency in Microsoft Word, Excel and PowerPoint