Start Up Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Maintains current knowledge of relevant country regulations, and GCP and ICH
  
  

• Create, review and customization of country/site specific Informed Consent Forms
  
  

• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site / review board engagements to efficiently drive new work
• Understand and comply with procurements, legal and financial requirements, and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Applied knowledge of project management processes and skills
• 2-5 years’ experience in clinical development, with some experience in clinical research/ Involvement in cross-functional clinical trials/experience in supporting the operational
  
  

• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem-solving skills and demonstrated ability to meet timelines.
• Self-management and organizational skills.
• Knowledge of Good Clinical Practice and understanding of the overall drug development process.