Study Start Up Associate - Medical Device
I
ICON Clinical Research
📍 Remote, United States, United States
Job Description
Study Start Up Associate - Medical Device - Home Based (US)
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.
**What you will be doing:**
Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the SSU Associate II conducts **clinical trial site start-up activities** related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:
+ IRB submissions and approvals.
+ Site informed consent form (ICF) customizations & negotiations.
+ Essential regulatory document collection.
**The...
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.
**What you will be doing:**
Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the SSU Associate II conducts **clinical trial site start-up activities** related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:
+ IRB submissions and approvals.
+ Site informed consent form (ICF) customizations & negotiations.
+ Essential regulatory document collection.
**The...