What You’ll Do:
• Review protocols to determine study-specific inclusion/exclusion information. Evaluate for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria.
• Set up screenings for participants. Determine the number and times of screenings and physicals to meet team and staffing needs. Keep the Senior Research Technician staff apprised of screening times to ensure adequate help with procedures. Arrive 15 minutes prior to scheduled screening with complete screening paperwork for the required number of screening participants.
• Conduct the Informed Consent session by reading aloud the most recently approved version of the Informed Consent to volunteers while they follow along with their own copies.
• Ensure each subject screened has been properly consented, has a signed informed consent, and all questions answered prior to any procedures being performed and continuing in the screening process.
• Ensure all study participants’ paperwork is complete and adequately reflects their participation in the study screening process. Ensure all subjects’ and screening failure paperwork is kept with the study to meet FDA requirements.
• Ensure physician reviews all clinical labs, ECGs, and other tests as required.
• Develop screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. Include documents such as Medical History, Physical Exams, Study Dates and Information, Study Demographics, Study Admission Records, Alcohol/Tobacco Consumption, Screening Log, Sign-in Sheets, Volunteer Tracking Form, and any other form required. Review computerized phone-screening tool for accuracy.