(Senior) Clinical Research Associate (New Zealand Wide & home-based)
New Zealand
Category Healthcare & Nursing Jobs
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). BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.
When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 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 require Conducts co-monitoring visits, if required Ensures 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 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 task as assigned Qualification Required: Additional Job Description What we expect from the successful candidate: Bachelors level degree or above in life sciences, pharmacy, nursing or medical Understands clinical trial processes with a thorough knowledge of ICH a.
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