Senior Clinical Research Associate, SCRA

🔥 22 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 11%

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Manage and oversee clinical trials • Monitor clinical trial sites for compliance with study protocols, ICH-GCP, and regulatory requirements • Perform pre-study site selection, initiation, routine monitoring, co-monitoring, and close-out visits • Verify the accuracy, completeness, and integrity of case report forms and source documents • Identify and resolve site issues and provide training to site staff • Evaluate site practices and escalate quality issues as appropriate • Ensure proper documentation, timely data collection, and achievement of study milestones • Maintain communication with investigators, site staff, and internal project teams • Assist with regulatory and ethics submissions and site contract negotiations • Prepare monitoring visit reports and follow-up letters • Support audit readiness and participate in sponsor or regulatory inspections • Track recruitment and enrolment, CRF completion, and data query resolution • Collaborate with CRA Group/CRM and study team members on recruitment plans, contingency plans, and study execution • Attend onboarding, disease indication, project-specific, and general CRA training • Conduct Assessment Visits as requested • Assist in managing clinical trials and perform additional assigned tasks

🎯 Requirements

• Bachelor’s degree or higher in life sciences, pharmacy, nursing or medicine • >3.5 years of monitoring experience in clinical trials (CRA or Sponsor) • Strong understanding of ICH-GCP, clinical trial processes, and regulatory guidelines • Efficient use of Microsoft Word, Excel, PowerPoint, and Outlook • Fluent in written and verbal English • Must hold a valid driver’s license and well-maintained vehicle suitable for business travel • Ability to manage multiple tasks, prioritize effectively, and handle time-sensitive deadlines throughout the study lifecycle

🏖️ Benefits

• Market competitive compensation package • Performance-based annual bonus scheme • Company shares (generous welcome grant!) • In-house and external learning and development opportunities • Fantastic benefits program

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