Senior Clinical Research Associate – Client-dedicated
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Sweden
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Job Level
Tech Stack
About the role
- Monitors investigator sites with a risk-based monitoring approach
- Applies root cause analysis (RCA), critical thinking and problem-solving skills
- Ensures data accuracy through SDR, SDV and CRF review
- Assess investigational product through physical inventory and records review
- Documents observations in reports and letters according to timelines
- Escalates observed deficiencies and issues to clinical management
- Participates in the investigator payment process
- Initiates clinical trial sites according to the relevant procedures
- Conducts on-site file reviews as per project specifications
Requirements
- University degree in a science related field
- Understanding of ICH-GCP, EU and FDA requirements
- Fluency in English
- Valid driver's license
- Proven clinical monitoring skills
- Experience from working on Cell & Gene Therapy studies
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Benefits
- health and wellness programs
- flexible working culture
- collaborative environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root cause analysisdata accuracyclinical monitoringinvestigational product assessmentfile reviewsmedical terminologyICH-GCPEU regulationsFDA requirementsCell & Gene Therapy studies
Soft Skills
critical thinkingproblem-solvingcommunicationorganizational skills
Certifications
university degree in a science related fieldvalid driver's license