Clinical Research Associate – Multiple Levels

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

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

• Perform remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Oversee necessary clinical trial documentation and sponsor procedures.

• Serve as a site processes expert to guarantee compliance with protocols, ICH-GCP, regulations, and SOPs.

• Monitor investigator sites utilizing a risk-based approach.

• Employ root cause analysis, critical thinking, and problem-solving techniques to identify issues and implement corrective/preventive measures.

• Ensure data integrity by reviewing SDR, SDV, and CRF.

• Evaluate investigational products through inventory and documentation review.

• Record observations in reports and correspondence.

• Highlight deficiencies and manage issues until resolution.

• Maintain communication with investigative sites between monitoring visits.

• Conduct monitoring activities in alignment with the approved monitoring plan.

• Participate in investigator payments and meetings.

• Identify potential investigators and initiate clinical trial sites.

• Execute trial closeout and retrieve trial materials.

• Ensure essential documents are complete and perform on-site file evaluations.

• Monitor trial progress and provide status updates.

• Maintain comprehensive and accurate study systems, including Clinical Trial Management Systems.

• Facilitate communication among sites, clients, and internal project teams.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete expense reports and timesheets.

• Contribute to project publications, tools, and initiatives for process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences-related discipline.

• Minimum of 1 year of clinical monitoring experience within a clinical setting, including clinical trials, medical terminology, medical research, clinical research, or healthcare.

• Experience in a health sciences field with formal training in medical terminology and anatomy may be taken into account.

• Valid driver's license when applicable.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be considered.

• Basic knowledge of medical/therapeutic areas and understanding of medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCPs, pertinent regulations, and procedural documents.

• Strong oral and written communication skills.

• Effective interpersonal abilities.

• Customer-oriented with strong listening skills and attention to detail.

• Excellent organizational and time management capabilities.

• Flexibility and adaptability to changing situations.

• Proficient in critical thinking, root cause analysis, and problem-solving.

• Competence in managing Risk Based Monitoring concepts and processes.

• Ability to work independently as well as collaboratively within a team.

• Proficient in Microsoft Office and quick to learn new software.

• Strong English and Polish language skills, including grammar.

• Willingness to travel more than 75% of the time.

🏝️ Benefits

• Competitive salary.

• Award-winning learning and development program.

• Flexible working environment.

• Work-life balance.

• Collaborative workplace culture.

• Opportunities for knowledge sharing and learning from colleagues.

• Comprehensive health and well-being benefits package.