Allucent is hiring a
Clinical Trial Associate

Summary

The job is for a Clinical Trial Associate at Allucent™. The role involves administrative support to clinical study teams, ensuring compliance with international regulations and guidelines. Key tasks include document quality checks, submission, and maintenance, site file preparation, query resolution, and maintaining various systems.

Requirements

• High School Diploma/Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalence (BS/BA) preferred
• Good Documentation Practices Knowledge
• Good Clinical Practices Knowledge
• Strong command in English language, both written and verbal

Responsibilities

• 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

Preferred Qualifications

• At least 1 year of experience in clinical research on CRO side is preferred
• Experience using eTMF, ISF/ISP is preferred

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms