Clinical Research Associate I, II, Senior

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/3/2026full-timeMalaysiaSeniorWebsite

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, data accuracy verification, and effective communication with clinical teams and investigative sites.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP ComplianceRisk Based MonitoringEffective CommunicationCritical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSource Document ReviewData VerificationRegulatory ComplianceRoot Cause AnalysisDocumentation ManagementMonitoring Report PreparationInvestigator Site AssessmentTrial Closeout ProceduresMedical Terminology

Soft Skills

Attention to DetailInterpersonal SkillsOrganizational SkillsTime ManagementFlexibility

Tools & Technologies

Microsoft OfficeClinical Trial Management Systems

Certifications & Qualifications

Bachelor's Degree in Life ScienceRegistered Nursing Certification

Industry Keywords

Clinical ResearchProtocol ComplianceSOPsInvestigational Product ManagementProcess Improvement

About the role

Key responsibilities & impact

Perform and coordinate clinical monitoring and site management activities
Conduct remote and on-site visits to assess protocol and regulatory compliance
Manage required documentation and sponsor or monitoring-environment procedures
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
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
Prepare timely monitoring reports and letters; escalate and follow issues through resolution
Maintain contact with investigative sites between monitoring visits
Track trial status and provide progress updates to the Clinical Team Manager
Update and quality-check clinical trial management systems
Participate in investigator meetings and identify qualified investigators
Initiate clinical trial sites and make compliance recommendations
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete and conduct on-site file reviews
Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
Facilitate communication among investigative sites, the client company, and the project team
Respond to company, client, and regulatory requirements, audits, and inspections
Complete expense reports and timesheets
Contribute to process improvement initiatives and other assigned project work

Requirements

What you’ll need

Bachelor's degree in a life science related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
2+ years of experience as a clinical research monitor or comparable experience
Valid driver's license where applicable
Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
Effective clinical monitoring skills
Understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated application 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
Effective oral and written communication skills with medical personnel
Customer focus, listening skills, attention to detail, and ability to identify underlying issues
Effective interpersonal, organizational, and time management skills
Flexibility and adaptability
Ability to work independently and as part of a team
Proficiency in Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to travel frequently, generally 60–80%, including possible extended overnight stays
Ability to comply with sponsor/client/site requirements, including disclosure of vaccination status or other personal information
Ability to work in environments involving potential exposure to biological fluids and infectious organisms, fluctuating temperatures, and required protective equipment

Benefits

Comp & perks

Sign-on bonus
Remote/hybrid work arrangement
Standard Monday–Friday work schedule
Frequent travel opportunities
Personal protective equipment provided/required as applicable