Principal 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.

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

• Ensure data integrity through SDR, SDV, and CRF evaluations during both on-site and remote monitoring.

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

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

• Report deficiencies and issues to clinical management and ensure resolution is followed through.

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

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

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

• Initiate clinical trial sites in alignment with protocol, regulatory standards, and ICH GCP requirements.

• Conduct trial closeout procedures and retrieve trial materials.

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

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

• Update study systems, including the Clinical Trial Management System, in accordance with study conventions.

⛳️ Requirements

• Bachelor's degree in a scientific discipline.

• Minimum of 7 years of independent monitoring experience in clinical development phases I-III.

• Knowledge of ICH-GCP and KGCP regulations.

• Proficiency in English.

• Demonstrated clinical monitoring abilities.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Capability to maintain an up-to-date understanding of ICH GCPs, relevant regulations, and procedural documents.

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

• Ability to manage Risk Based Monitoring concepts and methodologies.

• Effective oral and written communication abilities.

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

• Excellent organizational and time management capabilities.

• Strong interpersonal skills.

• Adaptability and flexibility.

• Ability to work both collaboratively in a team and independently.

• Proficient in Microsoft Office and a quick learner of relevant software.

🏝️ Benefits

• Sign-on bonus