Clinical Research Associate I

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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

• Complete the 12–14 week CRA Training Program, including instructor-led training, independent exercises, and in-field observation visits • Conduct site visits including PSSV, SIV, IMV, and COV • Function as site manager and build and maintain relationships with key site personnel • Monitor data quality and patient safety through monitoring and site education • Complete clinical monitoring activities in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs • Perform and coordinate assigned aspects of the clinical monitoring process to assess investigational product and/or medical device safety and efficacy • Determine protocol and regulatory compliance and prepare required monitoring documentation • Provide protocol and study training to assigned clinical study sites • Attend disease indication, project-specific, regional investigator meeting, and site booster training as required • Track enrollment, CRF data entry, protocol deviation trends, and overall site issues • Communicate site performance to the Clinical Study Team • Mentor or train less experienced CRAs as needed • Perform study-specific training with the project team • Reconcile Serious Adverse Events and resolve discrepancies with study sites and CST • Collaborate with CST and sites to deliver study milestones, including startup, recruitment, database analyses, and closeout • Support audit and inspection preparation and follow quality findings to resolution • Provide site-level management and co-monitoring support • Assist with other assigned clinical responsibilities within scope of the role

🎯 Requirements

• Fluent English is required; resumes/CVs must be submitted in English • BS/BA in a relevant scientific discipline • Experience working in oncology global trials and 5+ years of relevant Clinical Operations experience or 1+ years in a clinical research associate position is preferred • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Fluent in English (writing and speaking) • Proficient in Microsoft Word, Excel, PowerPoint and Outlook • Familiar with industry software such as CTMS, investigational product and data management systems • Ability to travel up to 70%

🏖️ Benefits

• Equal opportunity employment • Up to 70% travel

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