- Argentina
- Senior
- 5+ years
Senior Site Start up Associate
Responsibilities
- Forecasts submission/approval timelines and ensures they are adhered to
- Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified
- May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (or designee) during start-up on allocated projects
- Prepares ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules
- Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines
Requirements
- Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional