Senior Clinical Research Associate
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Job Description
Clinical research associate monitoring clinical trials for Thermo Fisher Scientific. Ensuring site compliance, data quality, and ICH-GCP standards across New Zealand.
Responsibilities:
- 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:
- 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:
- 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
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