CRA 1, Single-Sponsor Dedicated
On-site · Amsterdam, North Holland, The Netherlands
Job Summary
Perform site monitoring visits (initiation, monitoring and close-out) in accordance with contracted scope of work and regulatory requirements (GCP/ICH). Drive and track subject recruitment plans to meet project needs; administer protocol and related site training; establish regular communication with sites; evaluate site practices for protocol adherence and regulatory compliance; track regulatory submissions, recruitment/enrollment, CRF completion, data query resolution; maintain TMF/ISF; document site management findings and action plans; collaborate with study team; may support startup phase and recruitment plan development per site. Requires Bachelor's degree, at least 3 months of onsite monitoring experience, and Dutch proficiency (C1+).
Required Qualifications
- Bachelor's Degree Degree in scientific discipline or health care is required.
- At least 3 months of onsite monitoring experience is a must.
- Dutch proficiency at C1 level or above is a must.
- Written and verbal communication skills including good command of English language.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
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