Senior Clinical Research Associate
Thermo Fisher Scientific
Posted: 10/20/2026Clinical Research Associate II
Thermo Fisher Scientific
Posted: 10/20/2026
Clinical Research Associate
ICON plc
Posted: 10/9/2026Senior Clinical Trial Manager
ICON plc
Posted: 10/2/2026Senior Clinical Research Associate
Thermo Fisher ScientificCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical monitoring, ensuring compliance with FDA guidelines and ICH-GCP standards while effectively managing documentation and site relationships. Proficient in risk-based monitoring and critical thinking to enhance trial processes and data accuracy.
Highest-signal resume keywords
Clinical Monitoring ExperienceExpert Knowledge of FDA GuidelinesRisk Based Monitoring ProficiencyExcellent Communication SkillsStrong Attention to Detail
About the role
Key responsibilities & impact- Conduct and coordinate clinical monitoring and site management activities
- Conduct remote and on-site visits to assess protocol and regulatory compliance
- Manage required documentation, sponsor procedures, and monitoring guidelines
- Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
- Develop collaborative relationships with investigational sites and client personnel
- Support project and clinical team managers and lead assigned activities where required
- Mentor, train, and contribute to the development of junior clinical team members
- Monitor investigator sites using a risk-based monitoring approach
- Apply root cause analysis, critical thinking, and problem-solving to identify process failures and corrective/preventive actions
- Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
- Assess investigational product inventory and records
- Document observations in reports and letters and escalate deficiencies through resolution
- Maintain contact with investigative sites between monitoring visits
- Track trial status and provide progress reports to the Clinical Team Manager
- Update clinical study systems, including CTMS, and perform CTMS report quality-control checks
- Participate in investigator meetings
- Identify potential investigators and initiate clinical trial sites
- Ensure trial closeout and retrieval of trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
- Facilitate communication between sites, clients, and the PPD project team
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete expense reports and timesheets
- Contribute to process-improvement initiatives
Requirements
What you’ll need- Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification
- Considerable clinical research monitoring experience comparable to 5+ years
- Demonstrated high level of expertise in all aspects of clinical monitoring
- Expert clinical monitoring skills
- Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
- Excellent critical thinking, root cause analysis, and problem-solving skills
- Proficiency in Risk Based Monitoring concepts and processes
- Ability to evaluate medical research data
- Proficient knowledge of medical terminology
- Excellent oral and written communication skills
- Customer focus
- Excellent interpersonal skills
- Excellent organizational and time management skills
- Strong attention to detail
- Flexibility and adaptability
- Effective presentation skills
- Good digital literacy and proficiency in Microsoft Office
- Ability to travel frequently, generally 60–80%, including possible extended overnight stays
- Ability to work in an office, laboratory, clinical, and/or home office environment
- Ability to work upright and/or stationary for 6–8 hours per day
- Frequent mobility
- Ability to lift and carry 15–20 lbs
- Ability to access and use a variety of computer software
- Regular and consistent attendance
Benefits
Comp & perks- Annual incentive plan bonus
- Healthcare
- Employee benefits
- Career and development prospects
- Innovative, forward-thinking organization
- Company culture centered on integrity, intensity, involvement, and innovation
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 MonitoringRoot Cause AnalysisProblem-SolvingMedical Research Data EvaluationDocumentation ManagementProtocol ComplianceData Accuracy VerificationTrial Closeout ProceduresCTMS Report Quality-ControlMedical Terminology Proficiency
Soft Skills
Critical ThinkingInterpersonal SkillsOrganizational SkillsCustomer FocusFlexibility and Adaptability
Tools & Technologies
CTMSMicrosoft OfficeClinical Study Systems
Industry Keywords
ICH-GCP GuidelinesClinical TrialsRegulatory ComplianceInvestigational SitesProcess Improvement