Site Activation Specialist
Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.
- General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsible for one or more of the following functions at the country level:
- Local Submissions Specialist - Follows the project direction provided by the designated country startup advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during startup on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
- May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.
- Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution.
- Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
What we’re looking for:
- Associate’s Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
- Good English skills.
- Strong computer skills, including Word, Excel, PowerPoint, Publisher.
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