Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Performing clinical monitoring for assigned protocols and investigational sites with an accent on GCP compliance, regulatory requirements, and site management. Focus on conducting monitoring visits, reviewing source documents, and ensuring data integrity across clinical trials.

Location: Poland or Netherlands. Supports remote working, with a preference for a hybrid basis for those within commuting distance of offices.

Company

hirify.global provides expert consulting and end-to-end solutions to biotech, med device, and pharmaceutical organizations to accelerate drug and device programs.

What you will do

• Conduct various types of monitoring visits (initiation, interim, and close-out) both in person and remotely.
• Manage study start-up activities, including site identification, feasibility, and Ethics Committee submissions.
• Develop study-specific documentation, such as monitoring trackers, guidelines, and clinical monitoring plans.
• Review source documents and case report forms to ensure data accuracy, completeness, and integrity.
• Oversee investigational supplies, including dispensing, inventory, and reconciliation.
• Coordinate with investigators, sponsors, and cross-functional teams to resolve study needs and regulatory concerns.

Requirements

• Over 5 years of experience as a Clinical Research Associate.
• Bachelor's degree or an equivalent combination of education and experience.
• Proficiency with EDC, CTMS, IVRS, and eTMF systems.
• Comprehensive knowledge of ICH Guidelines, GCP, and local regulatory requirements.
• Excellent verbal, written, and interpersonal communication skills.

Culture & Benefits

• Commitment to diversity, equity, and inclusion, encouraging an authentic workplace.
• Flexible work arrangements supporting both remote and hybrid collaboration.
• Human-centric hiring process with personal reviews and no AI screening tools.
• Collaborative and entrepreneurial environment focused on scientific breakthroughs.