Clinical Trial Associate (USA)

at  Allucent

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.

REQUIREMENTS

• High School Diploma/Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalence (BS/BA) preferred
• Local to the Cary, NC, USA area and able to come into the office 2-3 times per week.
• Good Documentation Practices Knowledge
• Good Clinical Practices Knowledge
• Strong command in English language, both written and verbal.
• At least 1 year of experience in clinical research on CRO side is preferred
• Experience using eTMF, ISF/ISP is preferred.
• Excellent communication, organizational and listening skills
• Ability to confront constructively
• Fosters learning and the advancement and development of others
• Representative, outgoing and client focused
• Effective organizational, managerial, and time management skills
• Strong analytical and problem resolution skills
• Demonstrated ability to lead by example
• Demonstrated personal integrity and ethical values
• Demonstrated ability to see the bigger context and act appropriately
• Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external stakeholders
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint

• 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.