Clinical Research Associate II – FSP

🔥 12 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.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

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and case report form review • Assess investigational product inventory and records • Document observations in reports and letters • Escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payments and investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents comply with ICH-GCP and applicable regulations • Conduct on-site file reviews • Provide trial status and progress reports to the Clinical Team Manager • Update clinical study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications and tools • Contribute to project initiatives and process improvement

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Valid driver's license where applicable • Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Combination of appropriate education, training and/or directly related experience may be considered equivalent • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team

🏖️ Benefits

• Comprehensive health and wellbeing benefits • Wellness programs • Employee Assistance Program providing confidential support for personal and work-related issues • Flexible work arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company-paid parental leave • Paid volunteer time • Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops and mentorship programs • Learning and skill development opportunities

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