Clinical Process Specialist/Clinical Process Analyst

Hiringlink Solutions
  • Bangalore
  • 10-15 lakh
  • 3-10 years
  • 130 Views
  • 27 Aug 2015
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  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Good communication skills (written & verbal).
Hardcore monitoring experience in Clinical Trials
*Perform source document verification as per monitoring plan and ensure the source documents and other trial records are accurate, complete, kept up-to-date and maintained according to applicable SOP's to ensure complete records for example; Review of screening records, subject inclusion/exclusion criteria, and Informed Consent Forms, drug accountability records, Site Investigator File/ Trial Master File etc.
*Conduct monitoring of study activities as per monitoring plan
*Conduct Study close out visit: review of source documents/CRF, TMF, drug accountability
*Assist in preparation of Monitoring report writing and close looping of report.
*Establish and maintain primary communication with clinical sites and in-house and Field CRAs.
*Assist in development of monitoring plan after reviewing of IEC approved protocol; ICF; CRF.


Competencies/Skill sets for this job

CRF TMF Drug Accountability

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Hiringlink Solutions