Senior Clinical Research Associate

Work Schedule and Environment

This role follows a standard Monday to Friday schedule. The work environment includes office settings and frequent visits to clinical sites, with potential exposure to biological fluids requiring use of personal protective equipment. Travel is significant, with 60-80% travel expected, including extended overnight stays.

About the Role

As a Senior Clinical Research Associate, you will contribute to innovative clinical trials by monitoring investigator sites using risk-based approaches. You'll apply critical thinking and problem-solving to identify and resolve site process failures, ensuring data accuracy and regulatory compliance, thereby supporting the mission to improve global health and safety.

Primary Responsibilities

• Conduct monitoring activities both on-site and remotely, reviewing source data, case report forms, and investigational product inventories.
• Document findings timely using approved business standards and escalate issues for resolution.
• Maintain communication between visits to verify protocol adherence and data integrity.
• Participate in investigator payments, meetings, and site initiation and close-out activities.
• Ensure necessary regulatory and essential documents are complete and compliant.
• Mentor junior team members, assist in training, and contribute to project tools such as monitoring plans.
• Track trial progress and update project management systems accurately.
• Facilitate clear communication between sites, clients, and project teams.
• Respond to audits, inspections, and comply with company and regulatory standards.
• Complete administrative duties including expense reports and timesheets promptly.

Qualifications and Experience

• Bachelor's degree in a life sciences field, Registered Nursing certification, or equivalent formal qualifications.
• Valid driver's license as applicable.
• Minimum of 3 years' experience in clinical research monitoring or equivalent education/training.

Skills and Competencies

• Effective clinical monitoring expertise with knowledge of FDA guidelines, ICH GCP, and relevant regulations.
• Strong critical thinking with ability to perform root cause analysis and risk-based monitoring.
• Capacity to mentor others positively and evaluate medical research data with proficiency in medical terminology.
• Excellent oral and written communication tailored to medical professionals.
• Customer-focused with attention to detail, organization and time management skills.
• Adaptability to diverse scenarios and problem-solving in dynamic environments.
• Effective presentation capabilities.

Additional Information

• Relocation assistance may be available for experienced candidates from interstate or New Zealand.
• Competitive remuneration may include a sign-on bonus.

Benefits

• Comprehensive health and wellbeing programs including Employee Assistance Program.
• Flexible work arrangements to balance professional and personal commitments.
• Generous leave policies including purchase of additional leave, paid birthday leave and parental leave.
• Paid volunteer time for supporting charitable organizations.
• Opportunities for career growth through online courses, workshops, and mentorship programs.

Equal Opportunity Employer

Thermo Fisher Scientific values diversity and is an Equal Opportunity/Affirmative Action Employer committed to inclusivity without discrimination based on protected characteristics.