What are the responsibilities and job description for the Clinical Trial Assistant position at Meet Life Sciences?
Location: Cambridge, Massachusetts, United States ( On-Site)
No sponsorship
Clinical Trial Assistant (CTA)
Core Responsibilities
- Therapeutic areas: Oncology, Rare Disease and Neuroscience. ( MUST HAVE)
- Trial Master File (TMF) Management: Set up, maintain, and archive electronic and/or paper TMFs, ensuring compliance with ICH-GCP and company SOPs. Perform quality control checks to ensure completeness and audit readiness.
- Clinical Trial Management System (CTMS) Oversight: Enter and update study data, including site statuses, milestones, and team contacts.
- Transparency Reporting: Collect and track Transfer of Value (ToV) data related to healthcare professionals and organizations, ensuring compliance with regulations such as the EFPIA Disclosure Code and the U.S. Sunshine Act.
- Financial Tracking: Assist in budget forecasting and tracking, process purchase orders and invoices, and reconcile vendor payments.
- Administrative Support: Coordinate meetings (e.g., investigator meetings, steering committees), manage logistics, prepare agendas and minutes, and maintain shared study platforms.
- Vendor and Document Management: Liaise with vendors and CROs, manage study-related contracts and legal documents, and ensure timely collection and filing of essential documents.
Essential Qualifications
- Education: Bachelor’s degree in a scientific, clinical, or research field preferred; a 2-year relevant degree with additional experience may be considered.
- Experience: Minimum of 1–2 years in a clinical research or study management environment, either in academia, pharma, or CRO settings.
- Technical Skills:
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Familiarity with CTMS, eTMF systems (e.g., Veeva Vault), and financial tracking tools.
- Regulatory Knowledge: Understanding of Good Clinical Practice (GCP) guidelines and other clinical study regulations.
- Soft Skills:
- Strong organizational and time-management abilities.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively in a multidisciplinary team environment.
