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Clinical Research Associate II
Thermo Fisher Scientific. Perform and coordinate all aspects of clinical monitoring and site management .
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 guidelines and applicable regulations. Proficient in risk-based monitoring, critical thinking, and effective communication to facilitate trial processes and maintain data accuracy.
Highest-signal resume keywords
Clinical Monitoring SkillsICH-GCP KnowledgeRisk Based MonitoringCritical ThinkingDocumentation Management
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 ManagementProtocol ComplianceRoot Cause AnalysisData Accuracy VerificationSite AssessmentRegulatory ComplianceTrial Close-Out ProceduresMedical Terminology UnderstandingInvestigator Site IdentificationSDR, SDV, CRF Review
Soft Skills
Effective CommunicationOrganizational SkillsAttention to DetailFlexibilityInterpersonal Skills
Tools & Technologies
Clinical Trial Management System (CTMS)Microsoft Office
Certifications & Qualifications
Bachelor's Degree in Life SciencesRegistered Nursing Certification
Industry Keywords
Clinical ResearchRegulatory RequirementsSOPsInvestigational Product AssessmentMonitoring Environment Procedures
About the role
Key responsibilities & impact- Perform and coordinate all aspects of clinical monitoring and site management
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation and sponsor or monitoring-environment procedures
- Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
- 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, 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 payment processes and investigator meetings
- Identify potential investigators and initiate clinical trial sites
- Perform trial close-out and retrieval of trial materials
- Ensure essential documents are complete and maintained according to ICH-GCP and regulations
- Conduct on-site file reviews
- Provide trial status tracking and progress updates to the Clinical Team Manager
- Update study systems such as the Clinical Trial Management System (CTMS)
- Facilitate communication among investigative sites, the client company and the PPD project team
- Respond to company, client and regulatory requirements, audits and inspections
- Complete expense reports and timesheets
- Assist with project publications/tools and contribute to process-improvement initiatives
Requirements
What you’ll need- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 1 year as a clinical research monitor
- Valid driver's license where applicable
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- 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
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability
- Ability to work independently or in a team
- Microsoft Office proficiency and ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Benefits
Comp & perks- Travel requirement >75%
- Full-time employment