Principal CRA

Thermo Fisher Scientific

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

Posted 10/13/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP and applicable regulations while effectively communicating with investigational sites and project teams. Proficient in risk-based monitoring principles and maintaining accurate study documentation.

Highest-signal resume keywords

Clinical MonitoringSite ManagementICH-GCP ComplianceRisk-Based Monitoring (RBM)Critical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Source Data ReviewSource Data VerificationCRF ReviewInvestigational Product AccountabilityQuality ChecksClinical Trial Management Systems (CTMS)Medical TerminologyRegulatory RequirementsProblem-SolvingOrganizational Skills

Soft Skills

Effective CommunicationInterpersonal SkillsAttention to DetailTime ManagementCollaborative Approach

Tools & Technologies

Microsoft OfficeClinical Trial Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Qualification

Industry Keywords

Clinical ResearchInvestigational SitesAudit and Inspection ReadinessCorrective and Preventive ActionsStudy Documentation

About the role

Key responsibilities & impact

Manage and coordinate all aspects of clinical monitoring and site management
Perform remote and on-site monitoring activities using a risk-based monitoring approach
Conduct Source Data Review, Source Data Verification, and CRF review as applicable
Assess investigational product accountability through inventory and records review
Identify site process issues and implement corrective and preventive actions
Identify, document, escalate, and follow through on site deficiencies and issues until resolution
Maintain communication with investigational sites between monitoring visits
Ensure trials follow approved protocols, ICH-GCP, applicable regulations, SOPs, and procedures
Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements
Conduct on-site file reviews and support audit and inspection readiness
Initiate clinical trial sites and support site close-out activities
Participate in investigator meetings and support identification and assessment of potential investigational sites
Respond to company, sponsor, and regulatory audit and inspection requirements
Provide study status and progress updates to the Clinical Team Manager
Maintain accurate and timely information in study systems, including CTMS
Perform quality checks of CTMS-generated reports
Facilitate communication between sites, sponsors, and project teams
Contribute to project tools, communications, publications, process improvements, and best-practice sharing
Support additional study activities such as trip report reviews, newsletters, or leading CRA team calls
Participate in investigator payment processes
Complete expense reports and timesheets accurately and on time

Requirements

What you’ll need

Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or equivalent relevant academic/vocational qualification
At least 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience
Valid driver's license, where applicable
Equivalent combinations of education, training, and directly related experience may also be considered
Strong clinical monitoring and site management skills
Excellent understanding and practical application of ICH-GCP, applicable regulations, and clinical research procedures
Good knowledge of medical terminology and relevant therapeutic areas
Experience applying Risk-Based Monitoring (RBM) principles and processes
Strong critical thinking, root-cause analysis, and problem-solving capabilities
Excellent attention to detail with strong organizational and time-management skills
Effective written and verbal communication skills, including the ability to communicate confidently with medical professionals and investigational site staff
Strong interpersonal skills and a collaborative, customer-focused approach
Ability to adapt to changing priorities and work effectively both independently and as part of a global team
Proficiency in Microsoft Office and the ability to quickly learn clinical trial systems and software
Good written and spoken English
Strong presentation skills
Ability to travel frequently, typically 60–80%
Ability to drive regularly to clinical trial sites
Ability to undertake extended and overnight stays when required
Compliance with applicable sponsor, client, and investigational site requirements

Benefits

Comp & perks

The opportunity to work on innovative and diverse global clinical research programs
Exposure to a broad range of sponsors, therapeutic areas, and clinical trial environments
A collaborative and inclusive culture where your expertise and ideas are valued
Continuous learning, professional development, and opportunities for career progression
Competitive compensation and benefits
Appropriate personal protective equipment provided or required for exposure to biological materials