Clinical Research Associate – Sponsor: GSK

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 to pinpoint site process failures and propose corrective/preventive measures

• Guarantee data accuracy through SDR, SDV, and CRF evaluations during both on-site and remote monitoring

• Evaluate investigational products via physical inventory and record assessments

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

• Report deficiencies and issues to clinical management and ensure they are addressed through resolution

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

• Engage in investigator payment processes and resolution of findings

• Attend investigator meetings and identify potential qualified investigators in collaboration with the client

• Initiate clinical trial sites in accordance with protocols, regulations, and ICH GCP obligations

• Conduct trial closeout and retrieval of trial materials

• Ensure that 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 per agreed conventions, including Clinical Trial Management Systems

⛳️ Requirements

• Bachelor's degree in a science-related discipline

• Minimum of 2 years of independent monitoring experience in clinical development phases I-III

• Familiarity with ICH-GCP and KGCP standards

• Proficiency in English

• Demonstrated clinical monitoring capabilities

• 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

• Effective oral and written communication skills with medical professionals

• Customer-oriented mindset, excellent listening skills, and meticulous attention to detail

• Strong organizational and time management skills

• Proficient interpersonal skills

• Adaptability and flexibility

• Ability to work collaboratively within a team or independently

• Proficient knowledge of Microsoft Office and a willingness to learn relevant software

🏝️ Benefits

• Sign-on bonus

• Fully remote work arrangement