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An excellent career opportunity awaits a determined and motivated Clinical Research Associate who strives for excellence. If you want to build a stronger, more sustainable future and cultivate your career as a Clinical Research Associate, apply now!
Job Responsibility:
Deeply acknowledges and strictly follows SOPs, ICH-GCP guidelines and appropriate local and international legislation
Study and completely comprehend the protocol and other study related documents
Explain the purposes, the set- up and the procedures of the clinical trial to the investigators
Train and assist investigators in the conduct of clinical trials
Translate the study related documents to local language, if required
Conduct pre-study visits at potential investigational sites
Work with the Head of Regulatory for submission of study files to ethics committees and authorities
Prepare, check and update the Clinical Trial Files
Ensure centers are supplied with adequate study medication and verify drug accountability
Perform monitoring visits at the investigational sites
Prepare reports to document monitoring visits and telephone contacts
Prepare monthly trial status updates
Prepare sites for audits or regulatory inspections
Accurately complete timesheets and monthly expenses forms
Plan the month with the immediate supervisor
Participate in all formal activities of the clinical operations department
Act as the main link between the company and the investigator
Collaborate on feasibility evaluations, site screening and selection
Collaborate on study logistics, resources and planning
Handle financial issues of the study, including investigator payments
Ensure compliance with applicable quality standards
Manage timely subject enrolment and quality data collection