Clinical Trial Associate I

Allucent is a global full-service contract research organization dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.

Our clients have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for a Clinical Trial Associate I to join our team in Madrid - Spain! The Clinical Trial Associate (CTA) acts as 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. The CTA also assists the study team with the day-to-day conduct of international clinical studies.

Location: Madrid, Spain

Workplace: Office based

Key Responsibilities

eTMF

• 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.
• 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 Study Correspondence Management Plan

ISF/PSF

• 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.

Other Responsibilities

• Accurately updates and maintains site level CTMS, as needed and assist the project team with CTMS reports at requested intervals to follow-up on pending entries
• Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information
• May participate in feasibility and/or site identification activities.
• If required, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located