Senior Clinical Research Associate
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Slovakia
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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 to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Requirements
- Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
- Valid driver's license where applicable
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root-cause analysisdata accuracySDRSDVCRF reviewrisk-based monitoringclinical trial managementmonitoring activitiescorrective actionspreventive actions
Soft Skills
critical thinkingproblem-solvingcommunicationorganizational skills
Certifications
Bachelor's degree in life sciencesvalid driver's license