Senior Clinical Research Associate

🔥 12 minutes ago

🇳🇿 New Zealand – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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