Experienced Clinical Research Associate

Accountabilities: • Conduct site qualification, initiation, monitoring, and closeout visits in accordance with approved study protocols, Good Clinical Practice (GCP), standard operating procedures (SOPs), and applicable regulatory requirements.

• Build and maintain effective working relationships with clinical investigators, research physicians, study coordinators, and other site personnel.

• Assess investigator qualifications, training, staffing, facilities, laboratories, equipment, and other resources to ensure sites are adequately prepared to conduct clinical trials.

• Verify clinical data against medical records and source documentation, ensuring accuracy, completeness, consistency, and compliance with good documentation practices.

• Identify data entry errors, protocol deviations, and compliance issues, communicate findings to site teams, and recommend appropriate corrective actions.

• Confirm that participant recruitment and enrollment comply with study eligibility criteria, and assess site recruitment and retention performance while recommending improvements where needed.

• Review regulatory documentation and oversee investigational product accountability, inventory management, and related records.

• Verify the accurate reporting of adverse events, serious adverse events, concomitant medications, and relevant medical conditions in accordance with study protocols and reporting requirements.

• Prepare comprehensive monitoring reports and follow-up letters, documenting significant findings, deviations, deficiencies, and recommended actions to maintain site compliance and data quality.

Requirements:

• Bachelor's degree in a health-related or scientific discipline.

• At least 1.5 to 5 years of experience in clinical monitoring, preferably with demonstrated experience conducting clinical trial site visits and managing monitoring activities.

• Solid knowledge of clinical monitoring practices, clinical trial processes, GCP principles, regulatory requirements, and applicable SOPs.

• Ability to assess site performance, review clinical and regulatory documentation, identify compliance risks, and communicate findings effectively.

• Strong interpersonal, organizational, analytical, and problem-solving skills, with the ability to collaborate with multidisciplinary teams and manage competing priorities.

• Excellent written and verbal communication skills, including the ability to prepare clear monitoring reports and follow-up documentation.

• Confidence representing clinical monitoring expertise in internal and external meetings, including discussions with business development teams when required.

• Ability to work independently in a home-based environment while maintaining effective communication with study teams and research sites.

• Candidates based in Sydney, Brisbane, Adelaide, or Perth are preferred.

• Visa sponsorship or transfer may be available for qualified candidates already based in Australia.

Benefits:

• Flexible, home-based working arrangements and flexible working hours.

• No minimum monthly requirement for days spent on-site.

• Competitive compensation package and transportation allowance.

• Performance-based variable compensation, with bonuses calculated directly according to the number of monitoring visits completed.

• Annual merit-based salary increases.

• Accelerated, personalized training tailored to your existing experience.

• Opportunities to progress into senior and leadership positions, including Lead CRA, CRA Manager, and Clinical Trial Manager roles.

• Airline club allowance.

• Casual dress code.

• Opportunities for continuous professional development, cross-functional collaboration, and long-term career growth.

• A collaborative, science-driven environment focused on clinical research quality, innovation, and improving patient outcomes.

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