Clinical Trial Associate

Summary

Join Allucent™ as a Clinical Trial Associate (CTA) and provide primary administrative support to clinical study teams. You will ensure clinical trials adhere to international regulations and guidelines. Key responsibilities include quality checking and submitting documents to eTMF, maintaining study documents, preparing and distributing files for site visits, assisting with query resolution, and performing translations. The ideal candidate possesses a high school diploma or equivalent, good documentation and clinical practices knowledge, and at least one year of clinical research experience. Preferred qualifications include a bachelor's degree and experience with eTMF and ISF/ISP. Allucent offers a comprehensive benefits package, competitive salaries, professional development opportunities, flexible working hours, and remote/hybrid work options.

Requirements

• High School Diploma/Certificate or equivalent combination of education, training and experience
• Good Documentation Practices Knowledge
• Good Clinical Practices Knowledge
• Strong command in English language, both written and verbal

Responsibilities

• Perform quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing
• After quality check act as Document Submitter and submit country and site level documents to eTMF Document Inbox. Resolve rejections
• Assist with resolution of periodic QC findings for country and site eTMF
• If applicable, maintain study wet-ink documents temporarily in the local office and prepare shipment to the client at the end of the study
• Communicate with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status
• Update Expected Documents List (EDL) in eTMF for the country and site level
• Maintain Public Folders in accordance with the Study Correspondence Management Plan
• Prepare and distribute Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs)
• Prepare and maintain QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits
• Assist CRA with reconciliation of ISF/PSF vs. TMF and cooperate 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
• Perform translations, back-translations or verification of translations of study documentation when needed
• Accurately update and maintain site level CTMS, as needed
• If needed, assist the project team with CTMS reports at requested intervals to follow-up on pending entries
• Contribute to other areas of business as required

Preferred Qualifications

• Bachelor’s degree or equivalence (BS/BA)
• At least 1 year of experience in clinical research on CRO side
• Experience using eTMF, ISF/ISP
• 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

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