Start-Up Associate II; Italy

Position: Start-Up Associate II (Italy)
Description At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
Ensure planned dates are reliable and up to date in CTMS departments/study teams

File documents in the (e)
TMF for which they are the document owner

Assist other Study Start-up team members with filing documents in the (e)
TMF for which they are document owner

Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

Provide relevant documents in compliance with local regulation

Support review of technical, pre-clinical and clinical reports for regulatory submissions

Interact with regulatory authorities

Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

Interact with IEC/IRBPrepare and compile answers for questions raised by the IEC/IRB and submit the answers

Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

Assist in adapting country SIS/ISF to site-specific requirements

Provide country specific requirements to GSCM impacting site contracts’ process

Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

Negotiate within client approved contract and budget templates and negotiation parameters

Communicate with sites and internal personnel regarding the status of contracts and contract related documents

Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

Provide the final/draft CTA and site budget for submission, where required

Obtain site signature as well as Sponsor/Allucent signature, as applicable

Keep up to date with applicable local regulations impacting clinical trial contracts

Assist in preparing the site-specific Essential Document Package and sending to sites

Responsible for collection and first review of Essential Documents Provide the Global Essential Document Reviewer with the collected documents for independent review

Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

Obtain authorization for the shipment of Investigational Product to the site…