Czech Republic Job Openings
ICON
Senior Start Up Asociate
FULL TIME
August 5, 2024
JOB SUMMARY
- 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 procedures Provide feedback and shared learning for continuous improvement
- Bachelor/ Master degree
- Applied knowledge of project management processes and skills
- 2 years for SSU Associate II, min. 4 years’ experience on the similar position
- 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
Why ICON?
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