Clinical Trial Assistant

About the position

The Clinical Trial Assistant at Eisai will support all phases of clinical study activities, including feasibility, start-up, conduct, and close-out, under the supervision of Clinical Operations Leads. This role involves planning, creating, and communicating clinical study timelines, ensuring consistency across trials, and overseeing operational aspects in accordance with standard operating procedures and regulations. The position may be office-based or remote, requiring occasional commutes to the Nutley, NJ office.

Responsibilities

• Track and maintain study information and report on study progress as assigned.
• Attend internal study team meetings, prepare agendas, take meeting minutes, and distribute documentation.
• Assist with eTMF setup requests and filing project documentation in the eTMF within defined timelines.
• Perform eTMF internal reviews, reconciliation, and study file archival.
• Conduct detailed eTMF CRO quality check reviews and follow up for missing documentation under supervision.
• Provide general enrollment figures to the Clinical Operations Lead or leadership team as requested.
• Contribute to inspection readiness by creating and updating various folders and trackers for the eTMF and other documents.
• Maintain sponsor team member staff assignment lists for Eisai systems.
• Assist with tracking SAE safety reports and provide updates to the CRO.
• Initiate, track, and collate clinical trial documentation related to CSR appendices.
• Act as the central point of contact for the clinical team for designated projects and communications.
• Assist with creating, updating, and maintaining project trackers in EPIC.
• Support document preparation and follow-up, including Informed Consent Forms and Co-Monitoring Plans.
• Create Clinical Trial Agreement requests and coordinate reviews for essential materials.
• Assist in managing ancillary supplies with vendors/sites and follow up on action items.
• Attend CRO and vendor teleconferences as applicable and review regulatory packets for investigational product release.
• Provide user access management support and assist with investigator meeting planning.
• Track invoices and support the vendor reconciliation process.

Requirements

• Bachelor's Degree (US)
• Proficient in MS Outlook, Word, PowerPoint, and Excel
• Basic understanding of study-related documentation
• eTMF (Veeva) experience preferred
• Ability to work with global teams utilizing different media (email, virtual meetings, teleconferences)
• Good attention to detail
• Ability to multitask and show flexibility with changing project-specific priorities
• Effective communication across cross-functional teams, vendors, and CROs
• Demonstrate cooperative and professional behavior with colleagues and vendors
• Possess interpersonal skills to work with all functional areas and levels
• Strong organizational skills

Nice-to-haves

• Experience in clinical trial execution
• Knowledge of healthcare providers and KOL contributions

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities