We have a great opportunity for an experience freelance CRA who is looking to work for a major international CRO company on 6 months 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
• 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:
• min of 18 months of experience as CSC/CRA , Oncology experience highly desirable
• Experience in study-coordination including submissions, monitoring, document preparation, preparation of study report etc.);
• Experience as CRA in multicenter trial;
• Fluency in Dutch

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