Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
You will:
- Perform study startup activities and support all processes critical for site activation
- Collect site documents for IRB/IEC submission and/or IP-RED process
- File study-specific documentation in TMF, in accordance with Document management plan
- Assist in feasibility research and site identification, upon request
- Facilitate site agreement and budget negotiations
- Coordinate translation and review of study-specific documents
- Identify and escalate project-specific issues as needed
- Prepare and submit IP-REDs packages
- Ensure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites
- Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
- Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision