Clinical Research Associate II/Senior Clinical Research Associate – Multiple Therapeutic Areas

Thermo Fisher Scientific

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

Posted 11/12/2026full-timeRemote • United StatesSenior💰 $66,800 - $125,000 per yearWebsite

Core Competencies

Role fit

Core 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.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP KnowledgeRisk-Based MonitoringOncology Therapeutic ExperienceBachelor's Degree in Life Sciences

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical MonitoringProtocol ComplianceSource Data VerificationRoot Cause AnalysisData AccuracyTrial CloseoutDocumentation ManagementInvestigator Site AssessmentRegulatory ComplianceProblem-Solving

Soft Skills

Good Oral CommunicationGood Written CommunicationOrganizational SkillsTime ManagementPresentation Skills

Tools & Technologies

Clinical Trial Management SystemsMicrosoft Office

Certifications & Qualifications

Registered Nursing CertificationBachelor's Degree in Life Sciences

Industry Keywords

Clinical TrialsTherapeutic AreasOncologyOphthalmologyNeurologyCardiologyRare DiseaseRespiratoryObesityPulmonary

About the role

Key responsibilities & impact

Perform and coordinate all aspects of clinical monitoring and site management
Conduct remote or on-site visits to assess protocol and regulatory compliance
Manage required documentation, sponsor procedures, and monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
Ensure audit readiness and develop relationships with investigational sites
Monitor investigator sites using risk-based monitoring, root cause analysis, 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 approved monitoring plans
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 conduct on-site file reviews
Provide trial status tracking and progress updates to the Clinical Team Manager
Update study systems such as Clinical Trial Management Systems
Facilitate communication among 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, 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 drug screening
Bachelor's degree in a life sciences related field, or 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
Risk-Based Monitoring concepts and processes
Root cause analysis and problem-solving skills
Good 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
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, 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
401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) with company stock available at a discount
Fully remote work arrangement
Home office environment option