Clinical Research Associate, CRA Level I

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

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy.

• Utilize root cause analysis, critical thinking, and problem-solving skills to pinpoint site process failures and implement corrective and preventive actions.

• Ensure data integrity through the review of source documents, verification of source data, and assessment of case report forms during both on-site and remote monitoring activities.

• Evaluate investigational products through physical inventory assessments and records examination.

• Record observations in reports and correspondence in accordance with timelines and established business writing standards.

• Report deficiencies and issues to clinical management and ensure follow-up until resolution.

• Maintain communication with investigative sites between monitoring visits to verify protocol adherence, issue resolution, and timely data entry.

• Engage in investigator payment processes and address findings.

• Participate in investigator meetings and identify potential investigators for the client company.

• Initiate clinical trial sites in accordance with procedures, protocols, regulatory requirements, and ICH GCP obligations.

• Conduct trial close-out activities and retrieve trial materials.

• Ensure that essential documents are complete and conduct on-site file reviews.

• Provide trial status tracking and progress updates to the Clinical Team Manager.

• Update study systems as per agreed standards, including Clinical Trial Management Systems.

• Assist with project publications and tools, sharing insights with project team members.

• Contribute to project activities and process enhancement initiatives.

⛳️ Requirements

• Bachelor's degree in a science-related discipline.

• Comprehension of ICH-GCP, EU, and FDA regulations.

• Proficiency in English, French, and Dutch.

• Possession of a valid driver's license.

• Proven experience in clinical monitoring.

• Demonstrated knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, relevant regulations, and procedural documentation.

• Strong critical thinking, root cause analysis, and problem-solving capabilities.

• Ability to manage Risk-Based Monitoring concepts and procedures effectively.

• Excellent oral and written communication skills.

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

• Effective organizational and time management abilities.

• Strong interpersonal skills.

• Adaptability and flexibility.

• Capability to work both independently and as part of a team.

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

• Clinical Research Associate (CRA) experience across all study phases from initiation to close-out.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package emphasizing employee health and wellness.

• Flexible work culture.

• Focus on work-life balance.

• Collaborative work environment.

• Opportunities to share knowledge and enjoy time with colleagues.