Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a part of a Project Team.

• Initiate, supervise on-site and/or remote activities, and finalize study sites throughout the study process.

• Offer Unmasked Clinical Research Associate support for designated clinical studies.

• Oversee investigational product accountability and manage unblinded site operations.

• Ensure adherence to protocol and maintain study blinding and data integrity.

• Conduct clinical trial monitoring compliant with SOPs, GCP, ICH guidelines, and relevant regulations.

• Execute monitoring tasks to evaluate subject safety, data accuracy, and quality.

• Confirm informed consent procedures and compliance with protocols.

• Assess electronic or paper CRFs and source documentation for validity and precision.

• Document monitoring visit activities, observations, and corrective/preventive measures; update tracking systems and escalate issues as necessary.

• Communicate identified issues and required action items to sites.

• Deliver site documentation to eTMF or paper TMF.

• Verify maintenance of the Investigator Site File.

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

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

• 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 when requested.

• Mentor CRAs and create therapeutic-area training as needed.

• Contribute to capabilities presentations.

⛳️ Requirements

• Bachelor's Degree, preferably in life sciences or nursing; or equivalent experience.

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

• At least 1 year of experience as an unmasked monitor.

• Preferred experience in ophthalmology, particularly in retina indications.

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

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

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Capability to work autonomously and within a team matrix organization.

• Outstanding written and verbal communication skills.

• Proficiency in English and the local language.

• Strong organizational skills.

• Technologically adept with proficient software and computer skills.

• Self-aware, resolute, adaptable, collaborative, proactive, analytical, detail-oriented, coachable, and motivated to embrace new challenges; capable of facilitating discussions and exercising diplomacy in challenging situations.

• Ability to assume responsibility for assigned tasks.

• Proficient in managing complex or early-phase studies.

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

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• Collaborative and innovative team environment.

• Chance to impact the lives of patients positively.