CRA I - Senior Clinical Research Associate (FSP)

About the Role and Company

At Thermo Fisher Scientific, you will engage in impactful work contributing to global health improvements, supporting our mission to make the world healthier, cleaner, and safer. Our teams are empowered with the resources to pursue career growth while advancing science through cutting-edge clinical trials across more than 100 countries. We continuously develop innovative clinical research methodologies, including laboratory, digital, and decentralized trial services. As a Senior Clinical Research Associate (CRA I) within the FSP model, you will monitor clinical trials rigorously ensuring protocol adherence, subject rights protection, and data credibility.

Main Responsibilities

• Conduct risk-based monitoring of investigative sites using root cause analysis and critical thinking to identify and resolve site process issues, ensuring regulatory, protocol compliance and minimizing risks.
• Perform source data review, source data verification, and case report form evaluations via on-site and remote monitoring.
• Manage investigational product accountability through physical checks and documentation assessments.
• Prepare timely, well-structured monitoring reports and escalate concerns promptly to clinical management, following through to resolve issues.
• Maintain ongoing communication with investigative sites between visits to verify adherence and timely data entry.
• Lead site initiation, investigator qualification, and trial closeout activities ensuring compliance with protocol and regulatory requirements.
• Ensure critical trial documentation is complete and regularly reviewed in accordance with ICH-GCP guidelines.
• Provide study status updates and trial progress reports to Clinical Team Managers and update clinical trial management systems accurately.
• Facilitate effective communications between study sites, clients, and project teams using multiple forms of contact.
• Respond to audit and inspection requirements from company, client, and regulatory agencies.
• Complete administrative duties such as expense reports and timesheets promptly.
• Contribute to team knowledge by supporting project publications, tools, and suggesting process improvements.

Required Qualifications and Experience

• Bachelor’s degree in life sciences, Registered Nursing certification, or equivalent formal academic/vocational qualification.
• At least one year of clinical research monitoring experience or completion of a related drug development fellowship.
• Valid driver’s license if applicable.
• Essential therapeutic expertise in Oncology.

Skills and Competencies

• Demonstrated clinical monitoring expertise with thorough understanding of ICH GCP, regulatory guidelines, and procedural documents.
• Strong critical thinking abilities for root cause analysis and resolving site compliance issues.
• Ability to implement Risk-Based Monitoring principles effectively.
• Proficient communication skills for clear interaction with medical professionals and study teams.
• Excellent organizational skills with strong attention to detail and the ability to manage time effectively.
• Capability to work independently and collaboratively within teams.
• Good digital literacy, especially with Microsoft Office and clinical trial software tools.
• High level of English language proficiency including grammar and presentation skills.
• Must be Australian citizen or permanent resident.

Working Conditions and Location

This is a remote, home-based position preferably located in Western or Southern Australia. Standard office working conditions with a Monday to Friday work schedule apply.

Employee Benefits

• Comprehensive health and wellbeing programs including wellness initiatives and confidential Employee Assistance Program support.
• Flexible working arrangements to help balance professional and personal life.
• Generous leave options including paid birthday leave, company-paid parental leave, and ability to purchase additional leave days.
• Paid volunteer time to encourage charitable engagements.
• Access to continuous learning and career development opportunities through online courses, workshops, and mentorship programs.
• Competitive salary packages with annual bonuses and recognition as an Employer of Choice for Gender Equality.