Clinical Research Associate II/Senior, Oncology, Respiratory, Cardiovascular

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/4/2026full-timeUnited StatesSenior💰 $95,000 - $104,000 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, critical thinking, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP KnowledgeRisk Based MonitoringOral And Written Communication SkillsCritical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProtocol ComplianceRoot Cause AnalysisData Accuracy VerificationTrial Closeout ProceduresDocumentation ManagementSite AssessmentRegulatory ComplianceMedical TerminologyTime Management

Soft Skills

Problem-SolvingOrganizational SkillsPresentation Skills

Tools & Technologies

CTMSMicrosoft Office

Certifications & Qualifications

Bachelor's Degree In Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsInvestigational SitesAudit ReadinessSOPsSponsor Requirements

About the role

Key responsibilities & impact

Perform and coordinate clinical monitoring and site management activities
Conduct remote or on-site visits to assess protocol and regulatory compliance
Manage required documentation and sponsor/monitoring-environment procedures
Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Maintain audit readiness and collaborative relationships with investigational sites
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 closeout and retrieve trial materials
Ensure essential documents are complete and compliant
Conduct on-site file reviews
Provide trial status tracking and progress updates to the Clinical Team Manager
Update study systems such as 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
1–5 years as a clinical research monitor, depending on the level
Valid driver's license where applicable
Equivalent 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
Oral and written communication skills
Organizational and time management skills
Microsoft Office proficiency and ability to learn appropriate software
Good English language and grammar skills
Presentation skills
Ability to travel frequently, generally 60–80%; travel requirement >75%
Ability to work in office, laboratory, clinical and/or home office environments
Ability to comply with specific sponsor/client/site requirements
Ability to work upright and/or stationary for 6–8 hours per day
Ability to lift and carry up to 15–20 lbs
Regular and consistent attendance

Benefits

Comp & perks

Choice of national medical and dental plans, and a 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 in accordance with company policy
Competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP), with eligible colleagues able to purchase company stock at a discount
Variable annual bonus based on company, team, and/or individual performance results