Senior Clinical Research Associate
W
WEP ClinicalClinical Research
Remote, NetherlandsFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5–7+ years
- Required Skills
- GCPMS Office
Requirements
- Bachelor’s degree (life sciences, nursing, or related field preferred).
- 5–7+ years of experience conducting on-site and remote monitoring visits or equivalent clinical research experience.
- Broad therapeutic exposure across multiple study types and indications.
- Strong technical and scientific aptitude with the ability to quickly grasp and execute clinical protocols.
- Advanced organizational and logistical skills to manage multiple sites and protocols within timelines.
- Excellent written and verbal communication skills with confident stakeholder engagement.
- Solid understanding of medical terminology and therapeutic areas.
- Proven ability to train, coach, and mentor clinical research staff.
- Proficiency with MS Office and EDC systems.
- Willingness to travel up to 80%.
Responsibilities
- Contribute to the design and review of study documents including protocols, CRFs, ICFs, and study plans.
- Lead site feasibility activities including distributing questionnaires, conducting SQVs, and recommending sites.
- Plan and conduct SIVs, routine monitoring, and close-out visits in line with protocol and ICH-GCP requirements.
- Build and maintain strong relationships with site staff while providing protocol training and guidance.
- Verify source data and CRFs for completeness and ensure all site files are audit-ready.
- Review IP accountability, safety event documentation, and protocol deviations while driving corrective actions.
- Manage and resolve data queries, analyze error trends, and provide targeted retraining.
- Track and close action items and maintain clear oversight of monitoring deliverables.
- Support investigator meetings and contribute to the development of SOPs and monitoring tools.
- Oversee complex studies, finalize visit reports, and coordinate or mentor other CRAs as assigned.
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