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 initiation through to closeout.

• Evaluate the integrity of study implementation and adherence to protocols at sites, addressing any site-related issues.

• Cultivate strong relationships with investigators and site personnel.

• Ensure access to study systems and compliance with project-specific training requirements.

• Assess site staffing, documentation, communication, recruitment, compliance, and performance; implement corrective measures and follow up accordingly.

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

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

• Conduct qualification, initiation, monitoring, facilities assessment, and other on-site visits; perform remote contacts as needed.

• Create visit/contact reports.

• Oversee study supplies, accountability, destruction/return status, site payments, CRF entry, queries, and SAEs.

• Provide study-specific site training when necessary.

• Identify and communicate instances of study non-compliance, delays, and issues needing immediate attention, along with resolution strategies.

• Accomplish project goals and update clinical trial management systems, including CTMS, EDC, IVRS, SIS, and TMF documentation.

• Ensure assigned sites are prepared for audits and inspections while maintaining ICH-GCP and regulatory compliance.

• Collaborate with project team members to plan effectively, meet objectives, and support deliverables.

• Delegate and oversee administrative tasks where appropriate, providing performance feedback.

• Maintain high standards of quality, timeliness, and efficiency in work; keep the manager updated on progress and issues.

• Develop subject-matter expertise and work autonomously with minimal supervision.

• Complete timesheets, expenses, metrics, and other assigned responsibilities.

⛳️ Requirements

• Open to considering experienced CRAs based in Melbourne, Sydney, Brisbane, or Adelaide.

• A minimum of 4+ years of CRA experience from Australia or New Zealand, specifically with oncology trial experience, is required.

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

• Educated to degree level (preferably in biological science, pharmacy, or a health-related discipline) or possess an equivalent nursing qualification or relevant experience.

• Strong problem-solving abilities.

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

• Advanced presentation skills.

• A client-focused approach to work.

• Professional interaction skills within a client organization.

• Flexible attitude towards work assignments and learning opportunities.

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

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

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

• Excellent interpersonal, verbal, and written communication skills.

• Effective time management abilities to meet study requirements, team objectives, and departmental goals.

• Developing capability to work across diverse cultures.

• Ability to thrive in a virtual team environment.

• Strong consulting skills and meticulous attention to detail.

• Willingness to accommodate extensive travel requirements.

• Possess a driver’s license where required.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness programs.

• Flexible working arrangements to support work-life balance.