About Me
• Good rapport in patient handling
• Submitting regulatory documents to IRB and Sponsor
• Submitting the clinical study agreement to OSP for review
• Attending investigator meetings
• Developing a preliminary budget and verify all costs
• Helping PI negotiate the study budget direct costs with sponsor to cover all costs F&A costs are not negotiable
• Preparing for study initiation
• Obtaining physician signatures
• Recruiting subjects
• Screening and scheduling subjects
• Getting voluntary subject consent
• Teaching subjects about protocol expectations for them
• Performing study/protocol procedures in a detailed, accurate manner
• Maintaining study files
• Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work
• Tracking subjects, avoiding lost to follow up
• Entering subject details in CRF
• Entering subject details in EDC
• Completing case report forms CRA for PI review and approval
counseling patients.
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$6/hr
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