Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Evaluate the quality and integrity of study site practices, manage study progress, and ensure proper documentation for the Trial Master File and Investigator's Site File.
Collaborate with study team members and potentially support development of recruitment plans and site financial management.
Matching Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Skills & Requirements
Must-have
Perform site monitoring visits
Ensure adherence to GCP and ICH guidelines
Manage study progress and data
Maintain Investigator's Site File
Create study documentation and reports
Nice-to-have
Drive subject recruitment plans
Effective time and financial management
Establish effective working relationships
Key Requirements
At least 3 years of on-site monitoring experience
Good Clinical Practice (GCP) and ICH guidelines knowledge
Proficiency in Microsoft Word, Excel, and PowerPoint