Clinical Research Associate, Level I/II

This is a fully remote position, open to applicants in Australia.

📋 Description

• Performs risk-based site monitoring (both on-site and remotely), ensuring adherence to protocols, data integrity (SDR/SDV/CRF), and accountability for investigational products; identifies issues through root cause analysis and drives corrective/preventive actions to resolution.

• Oversees site lifecycle activities encompassing feasibility, initiation, routine monitoring, and close-out, ensuring compliance with ICH-GCP, regulatory standards, and study protocols.

• Maintains thorough and accurate trial documentation and systems (e.g., CTMS), provides status updates to the clinical team, and supports investigator payments as necessary.

• Serves as the primary liaison among sites, sponsors, and the project team; escalates and resolves issues, assists with audits/inspections, and ensures continuous communication and performance at the site level.

• Contributes to team objectives and continuous improvement initiatives, while promptly completing administrative tasks.

⛳️ Requirements

• A Bachelor’s degree in a life sciences-related discipline or a Registered Nursing certification, or equivalent relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary to perform the role (equivalent to 1 year as a clinical research monitor) or completion of the PPD Drug Development Fellowship.

• A valid Australian driver’s license is required.

• Must be an Australian Citizen or Permanent Resident.

• Demonstrated clinical monitoring proficiency.

• Evident understanding of medical/therapeutic knowledge and medical terminology.

• Proven ability to acquire and maintain a working knowledge of ICH GCPs, relevant regulations, and procedural documentation.

• Strong critical thinking abilities, including a critical mindset and thorough investigation skills for effective root cause analysis and problem-solving.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication skills, with the ability to effectively engage with medical personnel.

🏝️ Benefits

• Become part of a company that places a high priority on your health and wellbeing, offering comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related matters.

• Achieve a balance between work and personal life with flexible arrangements.

• Enjoy generous leave policies, including the option to purchase additional leave, paid birthday leave, and company-paid parental leave.

• Make a difference through paid volunteer time to support non-profit organizations that resonate with you.

• Enhance your career with access to online courses through Thermo Fisher Scientific University Plus and LinkedIn Learning, as well as workshops and mentorship programs for ongoing learning and skill development.