Freelance Senior Clinical Research Associate / Oversight Monitoring Lead (Clinical Research)

Location: Netherlands; the position is associated with Ukraine or Ukrainian-speaking candidates.

Company

hirify.global provides consulting and operational expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Conduct and oversee in-person and remote monitoring activities, including site initiation, interim, co-monitoring, and close-out visits.
• Prepare monitoring reports and study-specific monitoring documentation in line with SOPs and local regulatory requirements.
• Support study start-up activities outside the US, including site identification, feasibility, essential documents, and Ethics Committee submissions.
• Train site personnel on protocol requirements, source documentation, and case report completion.
• Review source documents, case report forms, regulatory documentation, enrollment, protocol deviations, safety events, and laboratory abnormalities.
• Coordinate with investigators, site personnel, sponsors, project teams, and external partners to resolve study needs.

Requirements

• More than 5 years of experience as a Clinical Research Associate.
• Bachelor’s degree or an equivalent combination of education and experience.
• Experience with electronic data capture, CTMS, IVRS, and eTMF systems.
• Knowledge of applicable local laws, regulatory requirements, ICH Guidelines, and GCP.
• Strong communication, presentation, organization, prioritization, and problem-solving skills.
• Ukrainian-speaking capability or a connection to Ukraine is indicated in the role title.

Culture & Benefits

• Part-time freelance engagement at 0.1 FTE.
• Remote working is supported, while hybrid collaboration may be encouraged for employees within a reasonable commute of an office.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, and innovation.
• Applications are reviewed personally by the recruitment team without AI screening tools.