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Title Clinical Research Associate
Responsibilities • Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
• Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
• Recruit investigators
• Negotiate study budgets with investigators
• Obtain, review, and process regulatory and administrative documents from investigator sites
• Review and develop protocols
• Review and develop CRFs
• Coordinate and present at Investigators’ Meetings
• Participate in proposal meetings with potential clients
• Prepare and review Serious Adverse Event (SAE) reports
• Prepare project management reports for clients, project personnel, and PharmaNet management
• Resolve issues, questions, and requests for additional study supplies
• Review and approve monitoring trip reports
• Review and verify completed CRFs
• Review clinical data in-house
• Resolve queries of CRF data with study site personnel
• Review Tables and Listings generated from study data
• Author Clinical Study Reports
• Train and mentor CRAs on monitoring, internal procedures, and query resolution
Requirements • Bachelor’s Degree or RN
• Three and a half years’ experience in clinical research, data management, or regulatory affairs
• Twenty-four months’ field monitoring or equivalent experience
• Ability and willingness to travel 50-60% of the time
• Excellent organizational skills
• Ability to manage time and work independently
• Excellent written and oral communication skills
City Orlando
Country United States [US]
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