Senior Clinical Research Specialist

Há 16 horas

São Paulo, São Paulo, Brasil beBeeClinicalResearch Tempo inteiro R$900.000 - R$1.200.000
Clinical Research Associate II

BeOne Medicines 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.

Key Responsibilities:
  • Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices.
  • Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation.
  • Develop collaborative relationships with investigative sites, and study vendors.
  • Provide protocol and related study training to assigned clinical study sites.
  • Attend disease indication and/or project specific training, as required.
  • Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues.
  • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues.
  • Communicate site performance to the Clinical Study Team (CST).
  • Perform study-specific training with project team.
  • Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies.
  • Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
Requirements:
  • Bachelor's degree in a relevant field and a minimum of 2+ years of experience in Clinical Operations, with a minimum of 1+ years of monitoring experience.
  • Experience in global oncology trials is preferred.
  • Strong understanding of clinical trial processes, including ICH and associated regulatory guidelines.
  • Excellent communication and interpersonal skills.
  • Excellent organizational skills and ability to prioritize and multi-task.
  • Fluent in English (writing and speaking).
Travel:

Up to 70% travel expected.

Computer Skills:
  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Familiar with industry CTMS and data management systems.
Global Competencies:
  • Fosters Teamwork.
  • Provides 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.

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