Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a vital member of a Project Team

• Initiate, oversee on-site and/or remote activities, and conclude study sites during the study execution

• Offer unmasked Clinical Research Associate support for designated clinical trials

• Manage accountability for investigational products and supervise unblinded site activities

• Ensure compliance with protocols in alignment with study requirements and relevant regulations

• Evaluate subject safety, data integrity, and quality through mandated monitoring tasks

• Confirm adherence to informed consent procedures and protocol guidelines

• Examine electronic or paper CRFs and source documentation for accuracy and validity

• Document actions, findings, and corrective and preventive measures from monitoring visits; update tracking systems and escalate issues as necessary

• Communicate identified issues and necessary action items to study sites

• Submit site documents to eTMF or paper TMF

• Ensure Investigator Site File maintenance complies with GCP, ICH, and local regulations

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

• Engage in audit and inspection preparation and follow-up

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

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

• Conduct Assessment Site Visits upon request

• Mentor CRAs

• Create and implement therapeutic-area training programs

• Contribute to capabilities presentations

⛳️ Requirements

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

• Over 5 years of independent on-site monitoring experience

• Minimum of 1 year of experience as an unmasked monitor

• Preferred experience in ophthalmology, specifically in a retina indication

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

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

• Knowledge of Good Clinical Practice regulations and ICH guidelines

• Capability to operate autonomously as well as within a team matrix organization

• Exceptional written and oral communication skills

• Proficient in English and the local language

• Strong organizational skills

• Technologically adept with solid software and computer skills

• Self-aware, resolute, adaptable, collaborative, proactive, analytical, detail-oriented, open to coaching, motivated to embrace new challenges, skilled in discussion facilitation, and diplomatic in challenging circumstances

• Ability to take ownership of designated tasks

• Competence in managing complex or early-phase studies

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

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunities for personal and professional development

• Collaborative and innovative work atmosphere

• Chance to positively impact patients’ lives