Sr Clinical Trial Assistant, Oncology

In this role, you will help us develop a new drug modality for cancer and other diseases with unmet medical needs by working directly with Research and Development (R&D) functions to execute clinical trials. The Clinical Trial Associate provides administrative support to Clinical Operations. The primary focus of the position is to facilitate efficient clinical trial planning and execution. You will work in a nimble, dynamic, matrix environment with Clinical Trial Teams (CTT), investigative site staff and a variety of vendors and consultants to ensure trial delivery in accordance with SOPs, applicable regulations and guidelines. This individual will report directly to the Associate Director, Clinical Operations.

Responsibilities

• Develop and maintain study tools including trackers, spreadsheets, and filing systems for multiple studies
• Manage sample shipments to central/reference laboratories
• Set-up and maintain eTMF in compliance with SOPs/WIs and TMF plans
• Execute eTMF filing, reviews and reconciliation activities, including follow-up of QA/QC findings
• Serve as a member of the inspection readiness team; ensure eTMF is inspection ready and provide documents as requested during audits/inspections
• Submit and track purchase orders, study agreements and contracts
• Review and track invoices
• Set-up and manage site feasibility collection and reporting
• Route approval forms for essential study documents (e.g., informed consent, study plans, protocols)
• Provide initial and ongoing study information in support of clinical trial registration on public registries (e.g., ClinicalTrials.gov)
• Request country-level clinical trial liability insurance certificates
• Assist in planning and coordination of meetings including logistics, agenda preparation and distribution of meeting minutes and meeting materials
• Develop and maintain Clinical Operations file structure
• Manage system access for assigned studies
• May function as subject matter expect for one or more clinical systems (e.g., eTMF, CTMS)
• Provide documents required for regulatory submission (e.g., FDA Form 1572) to Regulatory Affairs
• Participate in development and maintenance of Clinical Operations processes
• May function as a point of contact between clinical vendors as delegated by Program Manager
• May perform ad hoc study-related administrative tasks as assigned by Program Manager
• May perform site feasibility, study start-up/closure tasks as assigned by Program Manager

Qualifications

• BS./B.A. in life science or related field

Required Skills

• 2+ years of clinical operations experience
• Experience in biotechnology, pharmaceutical and/or CRO industry
• Solid attention to detail and excellent organizational skills
• Strong interpersonal and communication skills (both written and oral)
• Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization
• Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
• Creative problem-solving skills
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT and EDC platforms
• Ability to work on-site or remotely and attend in-person meetings
• Ability to work cross culturally and with a variety of time zones

Preferred Skills

• Phase 1/2 Oncology experience preferred
• Global trial experience preferred