Experienced Clinical Research Associate – CRA II, SR CRA

Thermo Fisher Scientific

. Perform and coordinate all aspects of clinical monitoring and site management .

Posted 9/15/2026full-timeRemote • California • United StatesJuniorMid-Level💰 $84,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP guidelines and applicable regulations. Proficient in risk-based monitoring, root cause analysis, and effective communication with investigative sites.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP KnowledgeRisk Based MonitoringRoot Cause AnalysisBachelor's Degree in Life Sciences

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Management SystemsSource Document ReviewSource Data VerificationCRF ReviewData Accuracy AssuranceTrial Closeout ProceduresRegulatory ComplianceProtocol AssessmentInventory ManagementProject Publications Assistance

Soft Skills

Critical ThinkingProblem-SolvingOrganizational SkillsInterpersonal SkillsAttention to Detail

Tools & Technologies

Microsoft OfficeStudy Systems

Certifications & Qualifications

Registered Nursing Certification

Industry Keywords

Clinical ResearchInvestigational SitesAudit ReadinessSOPsMedical Terminology

About the role

Key responsibilities & impact

Perform and coordinate all aspects of clinical monitoring and site management
Conduct remote and on-site visits to assess protocol and regulatory compliance
Manage sponsor procedures and guidelines across different monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Ensure audit readiness and develop collaborative relationships with investigational sites
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis to 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 through physical inventory and records review
Document observations in reports and letters and escalate deficiencies to clinical management
Maintain contact with investigative sites between monitoring visits and follow up on issues
Participate in investigator payment processes and findings resolution
Participate in investigator meetings
Identify potential investigators and initiate clinical trial sites
Perform trial closeout and retrieve 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 study systems such as Clinical Trial Management Systems
Facilitate communication between 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 and tools
Contribute to project work and process improvement initiatives

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
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
Equivalency combining 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 or in a team
Solid knowledge of Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to travel frequently, generally 60–80%, with up to 75% regional travel and possible extended overnight stays
Ability to work in office, laboratory, clinical, and/or home office environments
Ability to use required personal protective equipment

Benefits

Comp & perks

Variable annual bonus based on company, team, and/or individual performance results
Choice of national medical and dental plans
National vision plan, including health incentive programs
Employee assistance and family support programs
Commuter benefits
Tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave
Accident and life insurance
Short- and long-term disability
Competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount