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Unblinded CRA in Germany @ Fortrea

MunichOnsiteFull-time
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About this role

Join a sponsor-dedicated model supporting cutting-edge clinical trials in Germany. As an unblinded Clinical Research Associate , you will contribute to high-quality clinical research delivery while gaining strong exposure to unblinded study activities in a collaborative global environment.

Key Responsibilities

• You will perform unblinded monitoring activities in line with ICH-GCP guidelines and applicable regulations, including Investigational Product oversight • You will ensure protocol compliance, data integrity, and patient safety at assigned sites • You will maintain accurate and complete study documentation, including eTMF and regulatory files • You will build strong relationships with site staff, acting as the primary point of contact for site management (pharmacy only) • You could contribute to audit readiness and ensure inspection preparedness at site level

Required Qualifications

• Bachelor’s degree in Life Sciences or related field (or equivalent experience) • Initial experience in clinical research as a CRA with at least 1 year of monitoring experience • Understanding of ICH-GCP guidelines and clinical trial processes • Strong interest and knowledge in unblinded study conduct and Investigational Product management • Fluency in German and English (written and spoken) • Willingness to travel within Germany as required • Strong organizational skills with attention to detail

What We Offer

• Opportunity to work in a sponsor-dedicated environment on innovative studies • Structured onboarding and continuous development programs • Flexible working model supporting work-life balance • Access to global career growth opportunities within clinical operations • Inclusive and collaborative culture with employee resource groups and wellbeing initiatives

If you are looking to build your clinical monitoring career within a high-impact and supportive environment, we encourage you to apply and grow with us.

#LI-GQ1 #LI-Remote

Learn more about our EEO & Accommodations request here.

Skills

unblinded monitoringich-gcp guidelinesclinical trial monitoringinvestigational product managementprotocol compliancedata integrityetmfregulatory documentationsite management liaisoninspection preparednessgerman languageenglish languageorganizational skills

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