Senior Clinical Research Associate – FSP, with Sign-on Bonus

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

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy

• Implement root cause analysis, critical thinking, and problem-solving techniques to detect site process failures and recommend corrective/preventive measures

• Ensure data integrity through the review of SDR, SDV, and CRF during both on-site and remote monitoring

• Evaluate investigational products through physical inventory assessments and records analysis

• Record observations in reports and correspondence adhering to established timelines and professional writing standards

• Report deficiencies and concerns to clinical management and ensure their resolution

• Maintain communication with investigative sites between monitoring visits to verify protocol adherence and resolution of issues

• Engage in investigator payment processes and resolution of findings

• Attend investigator meetings and identify potential investigators for the client

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

• Conduct trial close-out activities and retrieve trial materials

• Ensure that essential documents are complete and carry out on-site file reviews

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

• Update study systems in line with agreed study conventions

⛳️ Requirements

• Bachelor's degree in a science-related discipline

• A minimum of 3 years of autonomous monitoring experience in clinical development phases I–III

• Familiarity with ICH-GCP and KGCP standards

• Proficient in English

• Demonstrated clinical monitoring abilities

• Knowledge of medical/therapeutic areas and medical terminology

• Practical understanding of ICH GCPs, relevant regulations, and procedural documentation

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

• Competence in managing Risk-Based Monitoring concepts and processes

• Excellent verbal and written communication skills

• Strong organizational and time management abilities

• Effective interpersonal skills

• Keen attention to detail

• Adaptability and flexibility

• Capability to work both collaboratively in a team and independently

• Proficient in Microsoft Office with the ability to learn relevant software

🏝️ Benefits

• Sign-on bonus

• Opportunities for both on-site and remote monitoring activities

• Full-time work schedule from Monday to Friday