Job expirat
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines
Recruit investigators for participation in clinical trials
Negotiate study budgets with investigators
Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
Review draft protocols for completeness and feasibility
Develop Case Report Forms for clinical trials
Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings
Prepare and process Serious Adverse Event (SAE) reports
Prepare project management reports for clients, project personnel, and PharmaNet management
Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
Resolve queries of CRF data with study site personnel
Review Tables and Listings generated from study data
Assist in writing Clinical Study Reports
Train junior CRAs on monitoring, internal procedures, and query resolution
When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority and to perform any other tasks necessary for or generally associated with the completion of these duties.
2 years' work experience in clinical research, data management, regulatory affairs, or relevant heakthcare research position
18 months' experience in field monitoring of clinical trials.
Good command of English
Ability to travel up to 50%
Clinical trials