Start-Up Associate

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 Contractor to join our A-team (hybrid*/remote) for up to 0.5 Fte! 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/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers