Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Job Summary
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
ICON offers a range of additional benefits including various annual leave entitlements, health insurance, competitive retirement planning, and a Global Employee Assistance Programme.
Matching Summary
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
Skills & Requirements
Must-have
ICH GCP guidelines compliance
site initiation and closure
regulatory document collection
clinical trial data verification
serious adverse event reporting
Oncology monitoring experience
Nice-to-have
highly responsive and proactive
team player
subject matter expert
advanced negotiating skills
Key Requirements
2-5 years clinical monitoring experience
5+ years clinical monitoring experience
Oncology monitoring experience required
feasibility/site selection/site start up experience
licensed health care professional or equivalent work experience
Work Rights
Must be legally authorized to work in the United States