Allucent is hiring a
Clinical Trial Associate

Summary

Join Allucent's A-team as a Clinical Trial Associate (CTA) and support clinical study teams at Country/Site level. As the primary administrative support, you will ensure compliance with international regulatory and local laws, and guidelines for Good Clinical Practice and Standard Operating Procedures.

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
• 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

Responsibilities

• Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing
• 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
• 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
• Assists the project team with CTMS reports at requested intervals to follow-up on pending entries
• Contribute to other areas of business as required

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