Senior Clinical Research Associate
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Research Associate: Overseeing clinical monitoring and site management to ensure protocol adherence, audit-ready documentation, and compliance with GCP and regulatory requirements with an accent on source data verification, safety event and deviation review, and driving corrective and preventative actions. Focus on leading site feasibility, conducting SIVs and routine monitoring (on-site and remote), and managing data queries to prevent recurring errors.
Location: Remote (Netherlands)
Company
partners with biopharmaceutical sponsors to deliver end-to-end clinical trial services and patient access solutions.
What you will do
- Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans).
- Lead site feasibility activities, including questionnaire distribution/collection, response evaluation, SQVs, and site recommendations.
- Plan and conduct SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements.
- Verify source data and CRFs for completeness, accuracy, and consistency; keep site files audit-ready.
- Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions.
- Manage and resolve data queries, analyze error trends, and provide targeted retraining; track and close action items within timelines.
Requirements
- Location: Must be based in the Netherlands
- Bachelor’s degree in life sciences, nursing, or a related field (preferred).
- 5–7+ years of experience conducting on-site and remote monitoring visits (or equivalent clinical research experience).
- Senior CRA experience level: SCRA I (3–5 yrs) or SCRA II (5+ yrs) with complex sites/regions, mentoring, and process improvement.
- Strong understanding of medical/therapeutic areas and medical terminology; excellent written and verbal communication for stakeholder engagement.
- Proficiency with MS Office and EDC systems; willingness to travel up to 80%.
Culture & Benefits
- Benefits and leave offerings for international hires may vary based on local regulations via an employer-of-record partner.
- Mission-driven environment focused on advancing clinical research and improving patient outcomes.
- Support for wellness, growth, development, and team relationships.
- Inclusive, supportive culture emphasizing integrity, accountability, and respect for diverse perspectives.
Hiring process
- Submit a resume in English via the Careers Portal or LinkedIn Easy Apply.
- Complete an Upwage AI screener if you receive a link; follow-up interviews are arranged by a team member.
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