Freelance Senior Clinical Research Associate

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

📋 Description

• Oversee clinical trials both on-site and remotely, adhering to SOPs, GCP, ICH guidelines, and relevant regulations.

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

• Confirm informed consent processes and ensure compliance with protocols.

• Examine electronic or paper case report forms (CRFs) and source documents.

• Validate the management and accountability of investigational products.

• Compile monitoring visit reports, document observations and corrective/preventive measures, and escalate issues as necessary.

• Share monitoring findings and action items with sites.

• Submit site documents to the electronic Trial Master File (eTMF) or paper TMF.

• Ensure proper maintenance of the Investigator Site File.

• Update the Clinical Trial Management System (CTMS) and other project systems with precise site information.

• Engage in audits and inspections, including preparation and follow-up activities.

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

• Assist Clinical Research or Project Managers with project tracking, monitoring plans, reports, and Clinical Research Associate (CRA) resource management.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training for therapeutic areas as required.

• Participate in capability presentations.

• Collaborate with study teams, investigative sites, and sponsors to ensure timely study delivery while maintaining data quality and blinding.

⛳️ Requirements

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

• 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 medications and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Capable of working independently as well as within a team matrix organization.

• Exceptional written and verbal communication skills.

• Proficiency in English and the local language.

• Strong organizational abilities.

• Technologically adept with good software and computer skills.

• Competence in managing complex or early-phase studies.

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

• Attributes such as self-awareness, determination, adaptability, collaboration, proactivity, analytical thinking, attention to detail, coachability, motivation, facilitation, and diplomacy.

• Capability to take ownership of assigned responsibilities.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.

• Collaborative and innovative work environment.

• Chance to make a meaningful impact in the lives of patients.