Freelance Clinical Research Associate

Freelance Clinical Research Associate

Home Based, Germany
We have a great opportunity for an experience freelance CRA who is looking to work for a global CRO company on 3 month contract basis.
Duties:
• Assesses investigator’s staff and facilities as appropriate
• Assists the preparation of regulatory submission package of appropriate documents according to local regulations.
• Ensures all local regulatory approvals are in place
• Reviews draft study documents and assist bin designed of the study documents.
Ensures proper local printing of the study supplies, if applicable
• Ensures local regulatory compliance
• Organizes and conducts pre-study activities and initiation visits to investigators and their staff, reviews protocol and study procedures and perform relevant trainings as appropriate.
• Reports issues in Monitoring Visit Reports and in SAE reporting procedures and initiates corrective actions.
• Ensures appropriate actions to fulfil Project Management activities deadlines in order to allow
• Data Management to perform data analysis for ongoing studies.
• Ensures filing of the study related documents according to GCP-ICH.
• Follows-up of SAE & International Safety Reports.
• Maintains accurate and up-to-date information in CTMS.
Required:
• 1-3 years experience as CSC/CRA
• Experience in study-coordination including submissions, monitoring, document preparation, preparation of study report etc.);
• Experience as CRA in multicenter trial;
• Fluency in German

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