Conducts risk-based site monitoring (on-site and remote), ensuring protocol compliance, data accuracy (SDR/SDV/CRF), and investigational product accountability; identifies issues using root cause analysis and drives corrective/preventive actions through to resolution.
Manages site lifecycle activities including feasibility, initiation, routine monitoring, and close-out, ensuring adherence to ICH-GCP, regulatory requirements, and study protocols.
Maintains complete and accurate trial documentation and systems (e.g. CTMS), provides status updates to the clinical team, and supports investigator payments where required.
Acts as the key liaison between sites, sponsor, and project team; escalates and resolves issues, supports audits/inspections, and ensures ongoing site communication and performance.
Contributes to team deliverables and continuous improvement initiatives, while completing administrative tasks in a timely manner.

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid Australian driver's license.
Australian Citizenship or Permanent Resident required.
Proven clinical monitoring skills.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
Ability to manage Risk Based Monitoring concepts and processes.
Good oral and written communication skills, with the ability to communicate effectively with medical personnel.

Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
Balance your work and personal life with flexible arrangements.
Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
Make an impact with paid volunteer time to support non-profit organizations that matter to you.
Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Clinical Research Associate, Level I/II

Key skills