Site Activation Specialist I

Overview

Site Activation Specialist I responsible for country-level site activation deliverables, regulatory and ethics submissions, and essential document support for clinical trials.

What you'll do

• Provide quality on deliverables at the country level, following project requirements and applicable country rules, with oversight from the SSU Country Manager.
• Work within forecasted submission and approval timelines, track milestone progress in the agreed SSU tracking system in real time, provide rationale for delays, assist with contingency plans and escalate issues as soon as identified.
• Monitor basic financial aspects of the project and the number of hours/tasks available per contract, and escalate discrepancies in a timely fashion.
• Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keep training records updated and ensure timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP and Sponsor requirements.
• Local Submissions Specialist: follow project direction from the designated country start-up advisor (CSA) and SAM, serve as point of contact for the SAM/PM (or designee) during start-up on allocated projects, and compile and/or review essential document packages for site activation, including essential document collection from site.
• Prepare and submit Central EC Applications, Local EC Applications, RA Applications and other local regulatory authority or hospital approval submissions as required and under supervision.
• Prepare ongoing submissions, amendments and periodic notifications required by central and local EC and RA and other local regulatory authorities, including safety notifications required by local rules, with oversight from the SSU Country Manager.
• Act as liaison and facilitator between investigational sites and functional leads for related tasks and issues.
• Oversee the site activation end-to-end process at country/site level.
• Local Site ID and Feasibility Support: support site selection lead and PM/SAM to ensure appropriate sites are selected based on clinical trial requirements.
• Local Investigator Contract and Budget Negotiator (as required): support the SAM in agreeing country template contract and budget, assist in producing site-specific contracts, assist in budget and contract negotiations with sites via the Site Contracts Service Centre and SAM lead with Sponsor until execution, and assist with quality control and arrange execution of CTAs and archival of documents with metadata capture.

Details

• Remote work (Canada).