Senior Clinical Research Associate, FSP

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

📋 Description

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

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

• Ensure the accuracy of data through SDR, SDV, and CRF assessments during both on-site and remote monitoring activities.

• Evaluate investigational products via physical inventory checks and records examination.

• Record findings in reports and letters adhering to established timelines and business writing standards.

• Raise deficiencies and concerns to clinical management and ensure they are addressed until resolution.

• Maintain communication with investigative sites between monitoring visits to verify protocol adherence, resolve issues, and ensure timely data entry.

• Engage in investigator payment processes and address findings collaboratively with project team members.

• Contribute to investigator meetings and assist in identifying potential investigators alongside the client.

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

• Conduct trial closeout procedures and collect trial materials.

• Ensure all essential documents are complete and conduct on-site file assessments.

• Monitor trial status and deliver progress updates to the Clinical Team Manager.

• Update study systems in accordance with agreed-upon conventions, including Clinical Trial Management Systems.

⛳️ Requirements

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

• Minimum of 5 years of independent monitoring experience across clinical development phases I-III.

• Familiarity with ICH-GCP and KGCP standards.

• Proficiency in English.

• Demonstrated clinical monitoring expertise.

• Knowledge of medical/therapeutic areas and medical terminology.

• Working understanding of ICH GCPs, relevant regulations, and procedural documents.

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

• Capability to manage Risk Based Monitoring concepts and processes effectively.

• Excellent oral and written communication skills.

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

• Effective organizational and time management abilities.

• Strong interpersonal skills.

• Adaptability and flexibility.

• Ability to work autonomously or collaboratively within a team.

• Proficiency in Microsoft Office and willingness to learn relevant software.

🏝️ Benefits

• Sign-on Bonus

• Fully Remote work arrangement