Senior Clinical Research Associate – Core Team

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

📋 Description

• Serve as Parexel’s primary liaison with designated clinical sites from the initiation of the study through to its closeout.

• Evaluate and ensure the integrity of study implementation and adherence to protocols at clinical sites.

• Engage in problem-solving to address and resolve issues arising at the sites.

• Foster relationships with investigators and site personnel.

• Facilitate site access to study systems and ensure compliance with project-specific training programs.

• Assess staff assignments and implement corrective actions and follow-ups as necessary.

• Tackle training, documentation, communication, and prior-visit challenges.

• Identify and assess potential issues related to data quality and integrity, implementing necessary follow-up actions.

• Participate in investigator meetings, as well as external and internal meetings, audits, and regulatory inspections.

• Collect, review, and approve updated or amended site and regulatory documentation.

• Evaluate site recruitment strategies and propose improvement plans.

• Conduct qualification, initiation, and other on-site visits, along with remote visits and communications as needed.

• Generate reports for visits and contacts.

• Assess site compliance and performance, recommending site-specific actions based on evaluations.

• Oversee and manage study supplies, including accountability and status of destruction or return.

• Review and follow up on site payments, CRF data entry, queries, and Serious Adverse Events (SAEs).

• Provide study-specific on-site training when applicable.

• Carry out assessments of site facilities.

• Communicate any study non-compliance, issues, delays, and changes, along with proposed solutions.

• Ensure the timely and accurate completion of project objectives and update trial management systems accordingly.

• Update and review data in CTMS, EDC, IVRS, and SIS, ensuring timely and high-quality site data entry.

• Manage and submit pertinent documents to the Trial Master File and distribute study materials to sites.

• Ensure that assigned sites are prepared for audits and inspections.

• Monitor compliance with ICH-GCP and relevant regulations.

• Delegate and review administrative tasks, providing performance feedback to management.

• Collaborate with project team members to achieve goals and facilitate effective project planning.

• Maintain high-quality, timely, and efficient delivery while keeping the manager well-informed.

• Develop subject-matter expertise while working with minimal oversight.

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

⛳️ Requirements

• A minimum of 4+ years of CRA experience from Australia or New Zealand.

• Experience in oncology trials.

• Site Management experience or equivalent background in clinical research.

• Understanding of clinical trial methodologies and terminology.

• A degree in biological science, pharmacy, or a related health discipline is preferred.

• An equivalent nursing qualification or other relevant experience is acceptable.

• Strong problem-solving capabilities.

• Ability to take initiative, work independently, and seek guidance when necessary.

• Advanced presentation skills.

• A client-focused mindset.

• Ability to engage professionally within a client organization.

• Flexibility regarding work assignments and willingness to learn new skills.

• Capacity to prioritize multiple tasks and meet project deadlines.

• Strong analytical skills and the ability for autonomous decision-making.

• Willingness to work in a matrix environment and appreciate teamwork.

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

• Excellent interpersonal, verbal, and written communication skills.

• Ability to assist others in achieving study/country deliverables while ensuring patient safety.

• Effective time management skills.

• Developing capability to work across different cultures.

• Ability to thrive in a virtual team environment.

• High attention to detail.

• Willingness to accommodate extensive travel requirements.

• A driver's license where applicable.

• Familiarity with ICH-GCP Guidelines, international and local regulations, Parexel SOPs, sponsor training requirements, and study-specific procedures.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement available for Australia-North Ryde.

• Potential consideration for experienced CRAs located in Melbourne, Sydney, Brisbane, or Adelaide.