Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a member of a Project Team.

• Initiate, oversee, and conclude study sites during the study execution, whether on-site or remotely.

• Deliver unmasked Clinical Research Associate support for designated clinical studies.

• Manage accountability for investigational products and supervise unblinded site operations.

• Monitor clinical trials in accordance with SOPs, GCP, ICH guidelines, and relevant regulations.

• Conduct monitoring activities to evaluate subject safety, data integrity, and overall quality.

• Verify compliance with informed consent procedures and protocol standards.

• Review electronic or paper CRFs and source documentation for accuracy and validity.

• Report on monitoring visit actions, findings, and corrective and preventive measures; update tracking systems and escalate any issues.

• Provide sites with identified concerns and necessary action items.

• Submit site documents to the eTMF or paper TMF.

• Ensure Investigator Site File maintenance adheres to applicable requirements.

• Update CTMS and other project systems with precise site-level information.

• Engage in audit and inspection preparation and follow-up tasks.

• Order, ship, and reconcile clinical investigative supplies when necessary.

• Support Clinical Research or Project Managers with project tracking, monitoring plans, report reviews, and CRA resource management.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training for specific therapeutic areas as needed.

• Take part in capabilities presentations.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing, or equivalent qualification.

• Over 5 years of independent on-site monitoring experience.

• A minimum of 1 year of experience as an unmasked monitor.

• Ophthalmology experience preferred, particularly in a retina indication.

• Capacity to thrive in a fast-paced environment with shifting priorities.

• Familiarity with basic medical terminology and scientific principles related to assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Ability to work autonomously and collaboratively within a team matrix organization.

• Exceptional written and verbal communication skills.

• Proficient in English and the local language.

• Strong organizational abilities.

• Technologically adept with solid software and computer skills.

• Capability to manage complex or early-phase studies.

• Willingness to travel up to 60–80%, including overnight and international travel when necessary.

• Self-awareness, resilience, flexibility, collaborative mindset, proactivity, analytical approach, attention to detail, coachability, and motivation to tackle new challenges while facilitating discussions and demonstrating diplomacy in challenging situations.

• Ability to take ownership of assigned responsibilities.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• Chance to positively impact patients' lives.