CRA - FSP - Denmark
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigational sites and manage clinical trial compliance across multiple sponsors. The role involves remote and on-site monitoring activities to ensure protocol adherence, regulatory compliance, and data integrity in support of global clinical trials.
Responsibilities
- Conduct remote and on-site monitoring visits using risk-based approaches to assess protocol compliance and regulatory adherence
- Review source documents, case report forms, and investigational product records; escalate deficiencies to clinical management
- Initiate clinical trial sites, perform investigator meetings, and manage trial closeout activities
- Ensure essential documents are complete per ICH-GCP standards and update clinical trial management systems
- Facilitate communication between investigative sites, sponsors, and project teams; respond to audits and inspections
Requirements
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year clinical research monitoring experience or PPD Drug Development Fellowship completion
- Proven clinical monitoring skills and understanding of ICH-GCP guidelines
- Strong critical thinking, root cause analysis, and problem-solving abilities
- Excellent written and oral communication skills with medical personnel
- Proficiency in risk-based monitoring concepts and clinical trial management systems
- Valid driver's license where applicable
Ledig stilling opslået Indrykket for 16 dage siden
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