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Clinical Trial Assistant
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We are seeking a highly skilled Clinical Trial Associate to join our team at Allucent. As a Clinical Trial Associate, you will play a critical role in supporting our clinical study teams at the country/site level, ensuring the smooth conduct of international clinical studies in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures.
Key Responsibilities- Document Management: Perform quality checks of documents prior to eTMF submission to ensure they meet specifications, are complete, and accurate for filing.
- Document Submission: Act as Document Submitter and submit country and site level documents to eTMF Document Inbox, resolving any rejections.
- QC Resolution: Assist with the resolution of periodic QC findings for country and site eTMF.
- Document Maintenance: If applicable, maintain study wet-ink documents temporarily in the local office and prepare shipment to the client at the end of the study.
- Communication: Communicate with the TMF Lead/Project Specialist to follow-up on country and site level eTMF status.
- EDL Updates: Update Expected Documents List (EDL) in eTMF for the country and site level.
- Public Folder Maintenance: Maintain Public Folders in accordance with the Study Correspondence Management Plan.
- ISF/PSF Preparation: Prepare and distribute Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs), or other files needed for Site Initiation Visits (SIVs).
- QC/Inventory Checklists: Prepare and maintain QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation for site visits and paperwork after site visits.
- Query Resolution: Assist CRAs/CTLs with query resolution and aged action item metrics follow-up internally.
- Translation and Verification: Perform translations, back-translations, or verification of translations of study documentation when needed.
- CTMS Updates: Accurately update and maintain site level CTMS, as needed.
- CTMS Reports: Assist the project team with CTMS reports at requested intervals to follow-up on pending entries.
- Education: High School Diploma/Certificate or equivalent combination of education, training, and experience; bachelor's degree or equivalence (BS/BA) preferred.
- Knowledge: Good Documentation Practices Knowledge, Good Clinical Practices Knowledge.
- Language Skills: Strong command in English language, both written and verbal.
- Experience: At least 1 year of experience in clinical research on CRO side is preferred.
- Technical Skills: Experience using eTMF, ISF/ISP is preferred.
- Soft Skills: 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.
- Computer Skills: Proficiency with various computer applications such as Word, Excel, and PowerPoint.
Allucent is a dedicated team of professionals committed 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.
Benefits- Comprehensive Benefits Package: Comprehensive benefits package per location.
- Competitive Salaries: Competitive salaries per location.
- Departmental Study/Training Budget: Departmental Study/Training Budget for furthering professional development.
- Flexible Working Hours: Flexible working hours (within reason).
- Remote/Hybrid Working: Opportunity for remote/hybrid working depending on location.
- Leadership and Mentoring Opportunities: Leadership and mentoring opportunities.
- Buddy Program: Participation in our Buddy Program as a new or existing employee.
- Internal Growth Opportunities: Internal growth opportunities and career progression.
- Financially Rewarding Employee Referral Program: Financially rewarding internal employee referral program.
- Online Training and Development: Access to online soft-skills and technical training via GoodHabitz and internal platforms.
