Clinical Trial Assistant - Eisai

Job Summary 

The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical study timelines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop recruitment strategy for the trial in program. 

This position may be office-based (hybrid) or remote based. For remote based, the selected candidate must be commutable to our Nutley, NJ office to be able to come into the office on an as-needed basis.
 

Essential Functions 

Clinical Trial Contributions: 

• Tracks and maintains study information and reports on study progress as assigned 

• Attends internal study team meetings; prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action items 

• Performs eTMF assist with set-up requests and 

• Assists with filing and archiving project documentation in the eTMF within the defined timelines 

• Performs eTMF internal reviews, reconciliation and study file archival 

• Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COL 

• Provides general enrollment figures to COL or leadership team as requested 

• Contribute to inspection readiness, including, but not limited to, creating and updating various folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO and vendors), internal study team meetings, country specific documents and all other documents as requested by Clinical Operations 

• Maintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRT 

• Assist with tracking SAE safety reports, collating information and providing updates to the CRO 

• Initiates, tracks and collates clinical trial documentation related to CSR appendices. 

• Act as central point of contact for the clinical team for designated projects, communications, and associated documentation 

Document Creation and Management: 

• Assist with creating, updating and maintaining project trackers in EPIC 

• Provides support for document preparation and follow-up (e.g. Informed Consent Form, eTMF fling plan, Co-Monitoring Plan) 

• Creates Clinical Trial Agreement requests using the legal tracker and follows-up on original agreements and amendments. Upload to Epic site 

• Coordinates reviews for essential materials such as ICFs and Co-monitoring plans 

CRO and Vendor Contributions: 

• Assist in managing ancillary supplies with vendor/sites 

• Assists COL with action Item follow-up 

• Attends CRO and vendor teleconferences as applicable 

• Review regulatory packet for investigational product release 

• Provide user access management support ; tracking certifications and maintain statuses of study team members 

• Assist with investigator meeting planning, including entering clinical meetings into Eisai internal systems 

• Attend investigator meeting when applicable 

• Performs other tasks or responsibilities as assigned 

Financial Contributions: 

• Track invoices and support the vendor reconciliation process 

• Adhere to financial standards, guidelines and compliance requirements 

Technical Competencies: 

• Functional development for resource planning. Become knowledgeable with the use of project tools and processes. 

• Develop foundational knowledge of healthcare providers and KOL contributions 

• Develop fundamental understanding for clinical trial execution, CRO responsibilities and the contributions of relevant functional areas 

• Tracks and completes individual expenditures (e.g., travel and expenses) as applicable 

• Follows function’s financial standards, guidelines and compliance requirements 

• Proficient with Outlook, Word, Excel and PowerPoint 

• Foundational understanding and usage of eTMF, Epic, EDGE, IRT, eDC and other Eisai internal systems as relevant 

Requirements 

• Bachelor’s Degree (US)   

• Proficient in MS outlook, word, power point and excel 

• Basic understanding of study related documentations 

• eTMF (Veeva) experience preferred 

• Ability to work with global teams utilizing different media (email, virtual meetings, teleconferences) 

• Must have 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 

• Possess strong organizational skills