职位描述：
Job Description
Senior Clinical Research Associate
Main duties
1.Study start-up preparation
-Get fully acquainted with all project and study specific issues.
-Inform and train investigator teams on these issues(with the help of the study PM) and get them organized.
-Organise investigator team meetings(in collaboration with the study PM and secretary)
-Open centers ASAP.
2.Monitoring(on-site part, in-house part)
-regular contacts with/visits to investigator centers(investigator, co-workers.others)
-Troubleshooting(study progress, deviations, pharmacovigilance issues,...)
-Data verification/quality control(source data verfication, coherence checks)
-Follow-up of investigator and sponsor(ICTR) files.
-Follow-up of all study Material(drug supplies and other)
-Occasional on-site visits with study project manager, clinical support manager trainees, QA auditors or study secretary.
-Cernre closure ASAP.
-Update data
-Write Montoring Visit report
-Give feedback to project team(and therapeutic division)
-Check SETHI for Quality Control at patient /center level.
-Assist Project Manager with the financial follow-up of the study.
-Check coherence of data
-Perform specific coding and translations whten needed
-Respect timelines of CRFs and DCFs.
Required competences and talents
-scientific background and clinical interest
-profound knowledge of good clinical practices,
-capacity instruct investigators and their team members,
-gifted organizer and coordinator
-Practical hands-on approach,
-Diplomatic skills(liaison between)investigator and company team)
-Willingness to travel.
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