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Senior Clinical Research Associate, FSP
Thermo Fisher Scientific. Monitor investigator sites using a risk-based monitoring approach .
About the role
Key responsibilities & impact- 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, issue resolution and timely data recording
- Participate in investigator payment processes and resolve findings with project team members
- Participate in investigator meetings and identify potential investigators with the client
- Initiate clinical trial sites according to procedures, protocol, regulatory and ICH GCP requirements
- Perform trial closeout and retrieve trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Track trial status and provide progress updates to the Clinical Team Manager
- Update study systems according to agreed conventions, including Clinical Trial Management Systems
Requirements
What you’ll need- University degree in a science related field
- At least 5 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
- Customer focus, listening skills and attention to detail
- Organizational and time management skills
- Effective interpersonal skills
- Flexibility and adaptability
- Ability to work independently or in a team
- Solid knowledge of Microsoft Office and ability to learn appropriate software
Benefits
Comp & perks- Sign-on Bonus
- Fully Remote work arrangement