Senior Clinical Research Associate – Freelance

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

📋 Description

• Effectively oversee designated investigator sites throughout the complete study lifecycle.

• Execute feasibility assessments, pre-study evaluations, site initiation, regular monitoring, co-monitoring, quality oversight, and close-out visits.

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

• Validate source data and confirm the precise completion of Case Report Forms (CRFs).

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

• Identify, document, and rectify protocol deviations and data inconsistencies.

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

• Ensure that site personnel are suitably trained and qualified.

• Monitor site performance metrics and tackle compliance or quality concerns.

• Escalate risks and issues while facilitating timely resolution.

• Support audit and regulatory inspection readiness initiatives.

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

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

⛳️ Requirements

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

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

• At least 1 year of experience in Ophthalmology clinical trials, including studies on 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 ability to independently conduct all types of monitoring visits.

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

• Willingness to travel within Poland as necessary.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• Collaborative and innovative work environment.