Clinical Research Associate

We are currently looking for a highly skilled and motivated CRA to share our mission to execute clinical research in an innovative, efficient, high‑quality and compliant manner to improve and save lives around the world.

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• Perform clinical study site management and monitoring activities in compliance with International Conference on Harmonisation – Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  
• Gain an in‑depth understanding of the study protocol and related procedures.
  
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
  
• Participate and provide inputs on site selection and validation activities.
  
• Perform remote and on‑site monitoring and oversight activities using various tools to ensure:
  
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  • Data generated at site are complete, accurate and unbiased.
    
  • Subjects’ rights, safety and well‑being are protected.
    
  
  
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close‑out visits and records clear, comprehensive and accurate visit and non‑visit contact reports appropriately in a timely manner.
  
• Collect, review, and monitor required regulatory documentation for study start‑up, study maintenance and study close‑out.
  
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits and inspections and overall site performance.
  
• Identify, assess and resolve site performance, quality or compliance problems and elevate per the defined Clinical Research Associate’s Escalation Pathway.
  
• Manage and maintain information and documentation to meet timelines.
  

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• Bachelor’s degree (or above) and at least 2 years of direct site management (monitoring) experience in the bio‑pharma‑CRO sector or an equivalent scientific/healthcare discipline with at least 5 years of relevant experience, including 2 years of direct site management.
  
• Ability to travel domestically, roughly 50% of working time.
  
• Hold a valid driver’s license.
  
• High sense of accountability/urgency; ability to prioritize and handle multiple tasks.
  
• Capability to lead and mentor CRAs on process/study requirements.
  
• Work effectively in a multicultural environment; ability to establish and maintain relationships.
  
• Fluent in English with excellent communication skills, able to understand and present technical information effectively.
  

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• Accountability
  
• Adaptability
  
• Adverse Event Report
  
• Clinical Data Management
  
• Clinical Development
  
• Clinical Research
  
• Clinical Research Organizations (CRO) Management
  
• Clinical Sciences
  
• Clinical Study Management
  
• Clinical Trial Compliance
  
• Clinical Trial Documentation
  
• Clinical Trial Management
  
• Clinical Trial Planning
  
• Clinical Trials
  
• Clinical Trials Monitoring
  
• Customer‑Focused
  
• Early Clinical Development
  
• Good Clinical Data Management Practice (GCDMP)
  
• Investigation Procedures
  
• IS Audit
  
• Medical Research
  
• Microsoft Office
  
• Patient Recruitment
  
• Pharmaceutical Management
  
• + 3 more
  

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

As an equal‑opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don’t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world. xcfaprz Please feel free to speak to us about what flexibility means to you during your application.