Senior Clinical Research Associate – Freelance

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Manage assigned investigator sites independently throughout the complete study lifecycle.

• Conduct feasibility assessments, pre-study preparations, site initiation, routine monitoring, co-monitoring, quality oversight, and close-out visits.

• Ensure that study milestones and site deliverables are met in accordance with established timelines.

• Verify source data and ensure the accurate completion of Case Report Forms (CRFs).

• Review informed consent documentation, regulatory files, essential documents, and records of investigational product accountability.

• Identify, document, and resolve any protocol deviations and data discrepancies.

• Prepare monitoring reports, follow-up communications, and correspondence with sites.

• Ensure that site personnel are adequately trained and qualified for their roles.

• Monitor site performance metrics and address any compliance or quality issues that arise.

• Escalate risks and issues while facilitating timely resolutions.

• Support activities related to audit and regulatory inspection readiness.

• Collaborate effectively with project teams, investigators, vendors, and cross-functional stakeholders.

• Participate in study meetings, training sessions, and various project-related activities.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related discipline.

• A minimum of 3–5 years of experience in independent clinical monitoring as a CRA or Senior CRA.

• At least 1 year of experience in Ophthalmology clinical trials, specifically in studies related to Retinopathy, Age-Related Macular Degeneration (AMD), and/or Diabetic Macular Edema (DME).

• Strong understanding of ICH-GCP, clinical trial regulations, and best practices in monitoring.

• Proven experience in independently conducting all types of monitoring visits.

• Exceptional site management, communication, and problem-solving abilities.

• Willingness to travel within the Czech Republic as needed.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.