Clinical Research Associate II
Thermo Fisher Scientific
Posted: 10/20/2026Senior Clinical Research Associate
Thermo Fisher Scientific
Posted: 10/20/2026
Clinical Research Associate
ICON plc
Posted: 10/9/2026Senior Clinical Trial Manager
ICON plc
Posted: 10/2/2026Clinical Research Associate II
Thermo Fisher ScientificCore 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 regulatory standards. Proficient in risk-based monitoring, data accuracy verification, and effective communication with investigative sites and clinical teams.
Highest-signal resume keywords
Clinical Monitoring SkillsICH GCP KnowledgeRisk Based MonitoringRoot Cause AnalysisClinical Trial Management Systems
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 sponsor procedures, guidelines and monitoring environments
- Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs
- Monitor investigator sites using a risk-based monitoring approach
- Apply root cause analysis and implement corrective/preventive actions
- Ensure data accuracy through source document review, source data verification and CRF review
- Assess investigational product inventory and records
- Prepare monitoring reports and letters and escalate deficiencies through resolution
- Maintain contact with investigative sites between monitoring visits
- Participate in investigator meetings and identify potential investigators
- Initiate clinical trial sites and perform trial closeout and retrieval of trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Provide trial status tracking and progress reports to the Clinical Team Manager
- Update clinical study systems, including Clinical Trial Management Systems
- 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
- Contribute to project publications, tools and process-improvement initiatives
- Travel frequently to site locations, generally 60–80%, potentially including overnight stays
Requirements
What you’ll need- Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
- At least 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Valid driver's license where applicable
- 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
- Organizational and time management skills
- Effective interpersonal skills and attention to detail
- Flexibility and adaptability
- Ability to work independently and as part of a team
- Solid knowledge of Microsoft Office and ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Benefits
Comp & perks- Fully remote work arrangement
- Full-time employment
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 MonitoringProtocol ComplianceData VerificationSource Document ReviewRegulatory ComplianceRoot Cause AnalysisRisk Based MonitoringTrial CloseoutMedical TerminologyProject Publications
Soft Skills
Critical ThinkingProblem-SolvingCommunication SkillsOrganizational SkillsInterpersonal Skills
Tools & Technologies
Clinical Trial Management SystemsMicrosoft Office
Certifications & Qualifications
Bachelor's Degree in Life SciencesRegistered Nursing Certification
Industry Keywords
Clinical ResearchICH-GCP GuidelinesSOPsInvestigational ProductMonitoring Reports