Senior Clinical Research Associate

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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 or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and ensure audit readiness • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF 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 supervising tasks according to the approved monitoring plan • Participate in investigator payments, meetings, findings follow-up, and project work • Identify potential investigators and initiate clinical trial sites • Perform trial close-out and retrieve trial materials • Ensure crucial documents are complete and compliant with ICH-GCP and regulations • Conduct on-site file reviews • Provide trial status tracking and progress reports to the Clinical Team Manager • Update clinical study systems, including the Clinical Trial Management System • 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 • Contribute to project publications, tools, and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification • Approximately 1 year of experience as a clinical research monitor • Proven clinical monitoring skills • Understanding of medical/therapeutic areas and medical terminology • Understanding 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 • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Solid Microsoft Office knowledge and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Australian citizenship or permanent residency required

🏖️ Benefits

• 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 • Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops and mentorship programs • Annual incentive plan bonus • Employee benefits • Competitive remuneration