Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based (m/w/d)
On-siteAmsterdam, North Holland, The Netherlands
Job Summary
Conduct site monitoring visits for selection, initiation, monitoring, and close-out in accordance with GCP and ICH guidelines. Adapt and track subject recruitment plans to enhance predictability while administering protocol training and establishing communication lines with sites. Evaluate site practices for protocol adherence and escalate quality issues as appropriate. Manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data query resolution. Maintain Trial Master File and Investigator's Site File documentation, submitting regular visit reports and follow-up letters. Collaborate with study teams to support project execution and development of per-site recruitment plans where applicable.
Required Qualifications
- Bachelor's Degree
- Degree in scientific discipline or health care
- Minimum of 3 years of independent, on-site monitoring experience as a CRA within a CRO or pharmaceutical environment
- Full professional fluency in both Dutch (minimum C1 level) and English
- Strong medical writing skills for reports
- 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)
- Organizational and problem-solving skills
- Exceptional interpersonal and cross-cultural communication skills
- A collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators
- Must be able to lift 50 lbs
Desired Qualifications
- Bachelor's degree, English major preferred
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