Clinical Research Associate II/Sr CRA, Multiple Therapeutic Areas

Thermo Fisher Scientific

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

Posted 9/15/2026full-timeRemote • Illinois • United StatesSenior💰 $66,800 - $125,000 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 regulatory standards. Proficient in risk-based monitoring, data accuracy verification, and effective communication with clinical teams and investigative sites.

Highest-signal resume keywords

Clinical Monitoring SkillsRisk Based MonitoringICH GCP KnowledgeBachelor's Degree in Life SciencesTherapeutic Area Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringRoot Cause AnalysisData VerificationProtocol ComplianceSite ManagementRegulatory ComplianceTrial CloseoutSource Document ReviewCRF ReviewInventory Assessment

Soft Skills

Critical ThinkingProblem-SolvingOrganizational SkillsInterpersonal SkillsCommunication Skills

Tools & Technologies

Clinical Trial Management SystemsMicrosoft Office

Certifications & Qualifications

Registered Nursing Certification

Industry Keywords

OncologyOphthalmologyNeurologyCardiologyRare DiseaseRespiratoryObesityPulmonarySOPsInvestigational Product

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, guidelines, and monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis to identify site process failures and corrective/preventive actions
Ensure data accuracy through source document review, source data verification, and CRF review
Assess investigational product inventory and records
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 payments and investigator meetings
Identify and initiate qualified clinical trial sites
Perform trial closeout and retrieve trial materials
Ensure essential documents are complete and conduct on-site file reviews
Provide trial status and progress reports to the Clinical Team Manager
Update clinical trial management systems
Facilitate communication between sites, the client company, and the PPD project team
Respond to company, client, and regulatory audits and inspections
Complete expense reports and timesheets
Assist with project publications, tools, process improvements, and other initiatives

Requirements

What you’ll need

1–2 years of traveling on-site monitoring experience
Therapeutic experience in at least one of: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary
Must live within 60 miles of the nearest major airport
Up to 80% travel expected
Must be legally authorized to work in the United States without sponsorship
Must pass a comprehensive background check, including a drug screening
Bachelor's degree in a life sciences related field, Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship
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
Ability to remain flexible and adaptable
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

Variable annual bonus based on company, team, and/or individual performance results
National medical and dental plans
National vision plan
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
401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) with company stock discount