Senior Clinical Research Associate – Contractor

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

📋 Description

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

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

• Engage in problem-solving to tackle and resolve site-related issues.

• Cultivate relationships with investigators and site staff.

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

• Assess site staff assignments and implement corrective actions along with follow-up measures.

• Address issues related to training, documentation, communication, and prior visits.

• Identify and assess data quality and integrity issues and take follow-up actions accordingly.

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

• Gather, review, and approve updated documentation from sites and regulatory bodies.

• Evaluate plans for site recruitment and suggest strategies for improvement.

• Conduct qualification, initiation, and both on-site and remote visits/contacts.

• Create visit/contact reports.

• Assess site compliance and performance, recommending specific actions as needed.

• Oversee the management of test articles/study supplies, including accountability and destruction/return status.

• Review and monitor site payment status, CRF data entry, queries, and SAEs.

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

• Conduct assessments of site facilities.

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

• Fulfill project goals and update relevant trial management systems.

• Collaborate with project team members on planning, objectives, and deliverables.

• Maintain CTMS and review site-level data within CTMS, EDC, IVRS, and SIS.

• Manage relevant documents in the Trial Master File and distribute study documents to sites effectively.

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

• Comply with ICH-GCP and applicable international and local regulations.

• Delegate and guide administrative tasks while providing performance feedback.

• Uphold high-quality work standards and foster collaborative relationships within a matrix environment.

• Keep the manager updated on progress and any issues that arise.

• Develop expertise in relevant subject areas.

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

⛳️ Requirements

• Open to considering Freelance CRAs with approximately five or more years of CRA experience, based in NSW, VIC, SA, or QLD; preference is for candidates in NSW and VIC.

• CRA experience in Australia is essential.

• Experience in oncology is preferred.

• Experience in site management or equivalent clinical research experience, with a solid understanding of clinical trial methodologies and terminology.

• A degree is preferred (biological science, pharmacy, or another health-related discipline) or an equivalent nursing qualification or comparable experience.

• Strong problem-solving abilities.

• Capable of taking initiative and working independently, while proactively seeking guidance when needed.

• Advanced presentation skills.

• A client-focused approach to work.

• Ability to interact professionally within a client organization.

• Adaptable attitude towards work assignments and willingness to learn new things.

• Capability to prioritize multiple tasks and meet project timelines, utilizing strong analytical skills for autonomous decision-making.

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

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

• Strong interpersonal, verbal, and written communication skills.

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

• Effective time management skills.

• Developing ability to work across diverse cultures.

• Ability to thrive in a virtual team environment.

• Excellent attention to detail.

• Willingness to accommodate extensive travel requirements.

• Possession of a driver's license where required.

🏝️ Benefits

• Independent Contractor role for a duration of 6 to 12 months (exact period to be determined later).

• Full-time position.