Clinical Trial Associate (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 Clinical Trial Associate (CTA) to join our A-team (hybrid*/remote). As a Clinical Trial Associate at Allucent, you will be the primary administrative support to Allucent clinical study teams at Country/Site level, to support Clinical Trial Operations and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member at Country/Site level.

In this role your key tasks will include:

• Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing.

• After quality check acts as Document Submitter and submits country and site level documents to eTMF Document Inbox. Resolves rejections.

• Assists with resolution of periodic QC findings for country and site eTMF.

• If applicable, maintains study wet-ink documents temporarily in the local office and prepares shipment to the client at the end of the study.

• Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.

• Updates Expected Documents List (EDL) in eTMF for the country and site level.

• Maintains Public Folders in accordance with the Study Correspondence Management Plan

• Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs).

• Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.

• Assists CRA with reconciliation of ISF/PSF vs. TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.

• Assist CRAs /CTLs with query resolution and aged action item metrics follow up internally.

• Performs translations, back-translations or verification of translations of study documentation when needed.

• Accurately updates and maintains site level CTMS, as needed.

• If needed, assists the project team with CTMS reports at requested intervals to follow-up on pending entries.

• Contribute to other areas of business as required.