CRA II - SCRA (Australia wide & Home-based) About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter).
Job Description: The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country. The CRA is responsible to deliver data within timelines and required quality standards, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
How you will add value: Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if required Conducts co-monitoring visits, if required Ensures that study milestones for sites responsible are met as planned Attends onboarding, disease indication and project specific training and general CRA training as required Documents monitoring activities appropriately following ICH-GCP and BeiGene standards Conducts Quality Oversight Visits (QOV), as requested Completes monitoring visit/QOV reports timely Assists with investigator/site identification Assists site to prepare Ethics Committee submissions Facilitates clinical trial site contract and budget negotiation Manages site queries and communications Assists in managing clinical trials, if required Establishes regular lines of communication with sites and COMs Provides protocol and related study training to assigned sites Evaluates the quality and integrity of site practices – escalating quality issues as appropriate Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution Collaborates with CRA Group/CRM to ensure recruitment plans and execute contingency plans, as needed Performs additional tasks as assigned Qualification Required: What we expect from the successful candidate: Bachelor's level degree or above in life sciences, pharmacy, nursing or medical Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry Excellent communication and interpersonal skills Excellent organizational skills and ability to prioritize and multi-task Fluent in English (writing and speaking) Applicant must have full Australian working rights to be considered. What We Offer To Our Valued Employees: Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan!) In-house and external learning and development opportunities Fantastic benefits program Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals. BeiGene Global Competencies: Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.
#J-18808-Ljbffr