Clinical Research Associate I/II – Core Team

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

📋 Description

• Serve as Parexel’s primary liaison with designated clinical sites, ensuring the integrity of study implementation and adherence to protocols.

• Foster relationships with investigators and site personnel.

• Facilitate access to study systems and guarantee compliance with project-specific training.

• Assess site staffing, documentation, communication, data quality, and data integrity; implement corrective actions and follow-up measures.

• Engage in investigator meetings, audits, and regulatory inspections.

• Collect, review, and authorize updated or amended site and regulatory documents.

• Analyze site recruitment strategies and propose enhancement plans.

• Conduct qualification, initiation, monitoring, facility assessments, and close-out visits, both on-site and remotely.

• Produce visit and contact reports.

• Review site compliance and performance, recommending tailored actions as necessary.

• Oversee test articles and study supplies, including accountability and their eventual destruction or return.

• Examine and follow up on site payments, CRF data entry, queries, and SAEs.

• Provide study-specific training to sites when needed.

• Identify and communicate the effects of non-compliance, issues, delays, and modifications on study timelines.

• Achieve project objectives and update clinical trial management systems accordingly.

• Maintain CTMS, EDC, IVRS, SIS, EDMS, and Trial Master File records with timely, high-quality data and documentation.

• Ensure that assigned sites are prepared for audits and inspections, complying with ICH-GCP and relevant regulations.

• Delegate and oversee administrative tasks while offering performance feedback.

• Stay informed about Parexel SOPs, sponsor requirements, study procedures, and applicable regulations.

• Keep the manager updated on progress and challenges, provide performance feedback, and cultivate subject-matter expertise.

• Complete timesheets, expense reports, metrics, and other assigned tasks.

⛳️ Requirements

• Required CRA experience from Australia or New Zealand, with a minimum of 1 year of independent monitoring.

• Experience in Site Management or an equivalent role in clinical research, with a solid understanding of clinical trial methodology and terminology.

• A degree in biological science, pharmacy, or a related health discipline, or an equivalent nursing qualification or experience.

• Strong problem-solving abilities.

• Capability to take initiative, work independently, and proactively seek guidance as needed.

• Advanced presentation skills.

• A client-focused approach and the ability to interact professionally within client organizations.

• Flexible attitude towards work assignments and new learning opportunities.

• Competence in prioritizing multiple tasks, adhering to project timelines, and making independent decisions using robust analytical skills.

• Willingness to operate in a matrix environment and value teamwork.

• Proficient computer skills, including CTMS, EDMS, Microsoft Excel, and Word.

• Excellent interpersonal, verbal, and written communication skills.

• Effective time management skills, capable of meeting study, team, and departmental objectives.

• Developing capability to work across various cultures.

• Ability to thrive in a virtual team setting.

• Exceptional attention to detail.

• Willingness to accommodate extensive travel requirements.

• Valid driver’s license where necessary.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.