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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. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com 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, responsible 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 requiredConducts co-monitoring visits, if requiredEnsures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)Attends onboarding, disease indication and project specific training and general CRA training as requiredDocuments monitoring activities appropriately following ICH-GCP and BeiGene standardsConducts Quality Oversight Visits (QOV), as requestedCompletes monitoring visit/QOV reports timelyAssists with investigator/site identificationAssists site to prepare Ethics Committee submissionsFacilitates clinical trial site contract and budget negotiationManages site queries and communicationsAssists in managing clinical trials, if requiredEstablishes regular lines of communication with sites and COMsProvides protocol and related study training to assigned sitesEvaluates the quality and integrity of site practices – escalating quality issues as appropriateManages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolutionCollaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as neededPerforms additional tasks as assignedQualification Required: Bachelor's level degree or above in life sciences, pharmacy, nursing or medicalUnderstands 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 industryExcellent communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskFluent 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 schemeCompany shares (generous welcome grant and performance-based annual equity plan)In-house and external learning and development opportunitiesFantastic benefits program and keep improvingPlus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.Join us and Make momentum in your careerBeiGene Global Competencies: Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity
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