Experienced CRA - Real World Evidence with SSU Experience

Location: Bucharest, Romania

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Perform site selection, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, regulations, and sponsor requirements.
• Coordinate Site Start-Up activities, including essential document collection, regulatory and ethics submissions, site activation, and follow-up of start-up timelines.
• Manage multiple sites and priorities across SSU, monitoring, and ongoing site management activities.
• Track regulatory approvals, site activation, recruitment, enrollment, CRF completion, data queries, and study milestones.
• Maintain regular remote communication with investigative sites, follow up on open actions, and document monitoring findings and action plans.
• Collaborate with study teams, SSU colleagues, regulatory teams, project management, sites, and clients.

Requirements

• Bachelor’s degree in a scientific, healthcare, or related field preferred; equivalent education, training, and experience may be accepted.
• At least one year of independent on-site monitoring experience.
• Experience with Site Start-Up activities, including essential documents, regulatory and ethics submissions, site activation, and start-up follow-up.
• Knowledge of clinical research regulations, Good Clinical Practice, and ICH guidelines.
• Strong organizational, prioritization, problem-solving, communication, and stakeholder-management skills.
• Good command of English required. Proficiency with Microsoft Word, Excel, PowerPoint, and relevant clinical research systems is expected.

Nice to have

• Experience in Real World Evidence, observational, non-interventional, registry, or post-authorization studies.
• Experience supporting subject recruitment planning or site financial management.

Culture & Benefits

• Full-time position combining on-site monitoring with frequent remote site management and SSU coordination.
• Reduced on-site monitoring frequency may apply depending on study design and project requirements.
• Opportunity to manage sites throughout the full study lifecycle.
• Work includes coordination with international clinical research and healthcare stakeholders.