Start Up Assiciate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Clinical Trial Start-up Associate role ensures that patients will have access to our clinical trials with the aim of making life better for our patients. The Associate is accountable for obtaining all approvals (Competent Authority and Ethical Review Board) to run the trial in the
EMEA and AMERIT Regions. The Associate will also have responsibility to ensure the investigator sites meet the requirement to enroll the study participants in the clinical trial and support maintenance and closeout activities. The Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Responsibilities

• 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
  Guidelines for clinical research.
• Create, review and customization of country/site specific Informed Consent Forms
  (ICFs).
• 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
  
• Populate Trial Master Files and libraries for future reference.

Provide feedback and shared learning for continuous improvement

Responsibilities

• 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
  Guidelines for clinical research.
• Create, review and customization of country/site specific Informed Consent Forms
  (ICFs).
• 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
  
• Populate Trial Master Files and libraries for future reference.
• Provide feedback and shared learning for continuous improvement

Requirements:

• 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
  activities of clinical trials.
• 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
  
• Bachelor’s degree preferably in a scientific or health related field, two years clinical
  research experience or relevant experience preferred.
• Language Fluency in English and Dutch is essential.