Freelance Senior Clinical Research Associate

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

📋 Description

• Operate as an integral member of a Project Team during the execution of clinical studies.

• Initiate, monitor both on-site and remotely, and conclude study sites.

• Provide unmasked Clinical Research Associate (CRA) support for designated clinical trials.

• Manage accountability of investigational products and supervise unblinded site activities.

• Monitor adherence to protocols, subject safety, data integrity, and overall study quality.

• Verify compliance with informed consent procedures and protocol specifications.

• Review electronic or paper Case Report Forms (CRFs) and source documentation.

• Document actions, findings, and corrective/preventive measures from monitoring visits.

• Appropriately escalate deficiencies and issues as they arise.

• Communicate with sites regarding identified issues and necessary action items.

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

• Ensure proper maintenance of Investigator Site Files.

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

• Engage in preparation and follow-up for audits and inspections.

• Order, ship, and reconcile clinical investigative supplies as needed.

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

• Conduct Assessment Site Visits as requested.

• Mentor CRAs and develop therapeutic-area training as necessary.

• Take part in capabilities presentations.

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

⛳️ Requirements

• Bachelor’s Degree in life sciences or nursing preferred; or equivalent experience.

• A minimum of 5 years of independent on-site monitoring experience is required.

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

• A minimum of 1 year of experience in Ophthalmology is preferred, ideally in a retina indication.

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

• Understanding of fundamental medical terminology and science related to assigned drugs and therapeutic areas.

• Familiarity with Good Clinical Practice regulations and ICH guidelines.

• Ability to work autonomously as well as within a team matrix organization.

• Exceptional written and verbal communication skills.

• Proficiency in English and the local language is essential.

• Strong organizational skills.

• Technologically adept with solid software and computer skills.

• Self-awareness, determination, adaptability, a collaborative mindset, proactivity, analytical thinking, and meticulous attention to detail.

• Willingness to be coached and a desire to embrace new challenges.

• Ability to facilitate discussions and exercise diplomacy in challenging situations.

• Capacity to take ownership of assigned responsibilities.

• Competence in managing complex or early-phase studies.

• Availability and willingness to travel up to 60–80%, including overnight and international travel if necessary.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• Chance to make a significant impact on patients' lives.