Clinical Research Associate

🔥 0 minutes ago

🇪🇸 Spain – Remote

💵 €46.1k - €57.6k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

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

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and applicable SOPs • Perform monitoring activities for selection, initiation, conduct, recruitment, quality data collection, and timely completion of oncology/hematology clinical trials • Collaborate with the Regional Clinical Operations Manager to adhere to study timelines and maintain quality standards • Identify gaps and areas for improvement and propose CAPA • Support study start-up and provide local expertise • Perform feasibility, site identification, selection, and evaluation • Provide protocol and related study training to assigned sites • Conduct pre-study, initiation, routine monitoring, and closeout visits • Conduct co-monitoring visits when required • Complete monitoring visit reports according to ICH-GCP, BeOne Medicines standards, and SOPs • Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution • Maintain communication with sites and report progress, issues, and proposed actions to Clinical Operations • Ensure inspection readiness of the study and sites • Collaborate with study sites to deliver study milestones, including startup, recruitment, database analyses, and closeout • Attend disease-indication-specific and general CRA training as required • Facilitate Study Oversight Visits, site audits, and/or inspections as required • Evaluate site practices and escalate quality and/or GCP issues • Anticipate and identify site issues, propose corrective and preventative actions, identify gaps, and promote operational excellence and innovation

🎯 Requirements

• BS in a relevant scientific discipline and minimum of 2 years of monitoring experience • Experience in oncology global trials preferred • Thorough knowledge of ICH and associated regulatory guidelines • At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry • Experience in oncology/hematology trials preferred • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Fluent in English & Spanish (writing and speaking) • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook • Willingness to travel up to 60%