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Clinical Research Associate, CRA
Thermo Fisher Scientific. Perform and coordinate clinical monitoring and site management activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP and regulatory standards. Proficient in risk-based monitoring, data accuracy verification, and effective communication with investigative sites and stakeholders.
Highest-signal resume keywords
Clinical Monitoring ExperienceICH-GCP KnowledgeRisk-Based MonitoringClinical Trial Management SystemsMedical Terminology
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DocumentationSource Document ReviewData VerificationCorrective Actions ImplementationTrial Closeout ProceduresRegulatory ComplianceMedical ResearchAnatomy KnowledgeCritical ThinkingRoot Cause Analysis
Soft Skills
Good Communication SkillsInterpersonal SkillsCustomer FocusAttention to DetailOrganizational Skills
Tools & Technologies
Microsoft OfficeClinical Trial Management Systems
Industry Keywords
Clinical TrialsHealth SciencesMedical TerminologyRegulatory RequirementsAudit Readiness
About the role
Key responsibilities & impact- Perform and coordinate clinical monitoring and site management activities
- Conduct remote and on-site visits to assess protocol and regulatory compliance
- Manage required clinical trial documentation and ensure audit readiness
- Monitor investigator sites using a risk-based monitoring approach
- Identify site process failures and implement corrective/preventive actions
- Ensure data accuracy through source document review, source data verification, and CRF review
- Assess investigational product inventory and records
- Document observations in reports and letters
- Escalate deficiencies and follow issues through resolution
- Maintain contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in investigator payments and investigator meetings
- Identify potential investigators and initiate clinical trial sites
- Perform trial closeout and retrieve trial materials
- Ensure essential documents are complete and compliant with ICH-GCP and regulations
- Track trial status and provide progress reports
- Maintain accurate and current study systems, including Clinical Trial Management Systems
- Facilitate communication among investigative sites, clients, and internal project teams
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete expense reports and timesheets
- Contribute to project publications, tools, process improvements, and other initiatives
- Travel more than 75%
Requirements
What you’ll need- Bachelor's degree in a life sciences related field
- At least 1 year of clinical monitoring experience in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
- Valid driver's license where applicable
- Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents
- Good oral and written communication skills with medical personnel
- Good interpersonal skills
- Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues
- Good organizational and time management skills
- Flexibility and adaptability
- Well-developed critical thinking, root cause analysis, and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Ability to work independently or in a team
- Solid knowledge of Microsoft Office and ability to learn appropriate software
- Good English and Hebrew language and grammar skills
Benefits
Comp & perks- Competitive salary
- Extensive benefits package focused on employee health and well-being
- Flexible working culture
- Work-life balance
- Award-winning learning and development programme
- Collaborative environment with opportunities to share expertise
- Professional and personal growth opportunities