- Prague, Prague, Czech Republic
- Full-time · Entry
- 1+ years
The role involves ensuring the accuracy, compliance, and timely approval of informed consent forms (ICF) for clinical trials, contributing to the ethical conduct of clinical research.
Compensation
Competitive base salary and performance related incentives
Responsibilities
- Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations.
- Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements.
- Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes.
- Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs.
- Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts.
Requirements
- Nice to have: Protocol interpreting & review