Senior Clinical Research Associate

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 10/22/2026full-timeRemote • New ZealandSeniorWebsite

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 investigative sites and clinical teams.

Highest-signal resume keywords

Clinical MonitoringICH-GCP ComplianceRisk-Based MonitoringClinical Trial ManagementEffective Communication

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Hard Skills

Clinical Trial DocumentationSource Data VerificationRoot Cause AnalysisRegulatory ComplianceMonitoring PlansData AccuracyInvestigational Product AssessmentPhase-I Study MonitoringProblem-SolvingCritical Thinking

Soft Skills

Interpersonal SkillsOrganizational SkillsTime ManagementAttention to DetailFlexibility

Tools & Technologies

Clinical Trial Management SystemsMicrosoft Office

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchMedical TerminologySponsor GuidelinesSOPsInvestigative SitesTrial Close-OutProcess 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 clinical trial documentation, procedures, and sponsor guidelines
Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
Monitor investigator sites using risk-based monitoring, including 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 and escalate deficiencies through resolution
Maintain contact with investigative sites between monitoring visits
Conduct monitoring tasks according to approved monitoring plans
Participate in investigator payments and findings resolution
Track trial status and provide progress reports to the Clinical Team Manager
Update and quality-check clinical trial management systems
Participate in investigator meetings and identify qualified investigators/sites
Initiate clinical trial sites and support regulatory and ICH-GCP compliance
Close out trials and retrieve trial materials
Ensure essential documents are complete and conduct on-site and remote file reviews
Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
Facilitate communication among investigative sites, clients, and the PPD project team
Respond to company, client, and regulatory audits and inspections
Complete expense reports and timesheets
Contribute to process improvement initiatives

Requirements

What you’ll need

Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Valid New Zealand driver's license and ability to drive
4+ years as a clinical research monitor or comparable experience
Monitoring experience in phase-I healthy volunteer studies
Effective clinical monitoring skills
Understanding of medical/therapeutic areas and medical terminology
Understanding and 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
Ability to communicate with medical personnel
Customer focus, listening skills, attention to detail, and ability to perceive underlying issues
Effective interpersonal, organizational, and time management skills
Flexibility and adaptability
Ability to work independently and in a team
Proficiency in Microsoft Office 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
Comprehensive Total Rewards package
Comprehensive health and wellbeing benefits
Wellness programs
Employee Assistance Program
Flexible arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company-paid parental leave
Paid volunteer time
Thermo Fisher Scientific University Plus online courses
LinkedIn Learning
Workshops
Mentorship programs