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

🔥 0 minutes ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters according to timelines and business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance and issue resolution • Participate in investigator payment processes and findings resolution • Participate in investigator meetings and identify potential investigators with the client • Initiate clinical trial sites in accordance with procedures, protocol, regulatory and ICH-GCP obligations • Perform trial close-out and retrieval of trial materials • Ensure 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 according to agreed study conventions

🎯 Requirements

• University degree in a science related field • At least 3 years of independent monitoring experience in clinical development phases I–III • Understanding of ICH-GCP and KGCP requirements • Fluency in English • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Flexibility and adaptability • Ability to work in a team or independently • Solid knowledge of Microsoft Office and ability to learn appropriate software

🏖️ Benefits

• Sign-on bonus • On-site and remote monitoring activities • Full-time work schedule, Monday–Friday