Start-Up Associate/Sr. Start-Up Associate - Contractor (USA)

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/Sr. Start-up Associate (Contractor) to join our A-team. As Allucent, you will coordinate and support local site start-up activities of Allucent Study Start-up & Site Intelligence. This may include essential record collection, Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities, and country and site Informed Consent (ICF) review. The Start Up Associate (Contractor) will support 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:

General activities
- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
- Ensure site start-up milestone planned dates are reliable and up to date in CTMS
- 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
- Complete handover of site to CRA at time of SIV

IEC/IRB submission/approval activities
- Assist sponsor and sites in the preparation, compilation, submission and maintenance of ethical requirements and documentation required by IEC/IRB for clinical trials at local level
- Providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
- Support in interactions with IEC/IRB
- Assist in the preparation and compilation of answers for questions raised by the IEC/IRB and submit the answers
- Complete adaptation of Master ICF to country and/ or site-specific requirements

Essential Document collection activities
- Assist in the preparation of the site-specific Essential Records Package and send package to sites
- Complete collection and first review of Essential Records
- 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

Other activities:
- May support feasibility and/or site identification activities
- May negotiate clinical agreements and budgets
- Contribute to other areas of business as required