The Clinical Trial Assistant (CTA) provides high-quality administrative and operational support to the Clinical Operations team for late-stage clinical trials. This is an excellent opportunity for an organized, detail-oriented individual who is early in their clinical research career and enjoys coordinating information, documents, meetings, and day-to-day study activities. The CTA will work closely with more experienced Clinical Operations colleagues, including the Senior CTA/TMF Specialist, to support Trial Master File (TMF) activities and help ensure study documentation is complete, accurate, organized, and maintained in a timely manner. This individual will contribute to the success of the team and organization while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.
Key Responsibilities
- Support the Senior CTA/TMF Specialist with routine TMF administration, including document collection, filing, indexing, quality checks, tracking, and follow-up activities in accordance with applicable GCP requirements and CellCentric SOPs.
- Provide administrative and operational support across the broader Clinical Operations team, helping coordinate activities, maintain organized documentation, and support team priorities as needed.
- Assist with the creation, compilation, organization, and maintenance of investigator site files and other study documentation.
- Maintain accurate and well-organized clinical trial documentation, following established processes and escalating questions or missing information to more senior team members.
- Maintain study trackers and support the coordination of study approvals, protocol amendments, essential documents, and other administrative updates.
- Provide logistical and administrative support for investigator meetings, site initiation visits, monitoring visits, and other study activities.
- Assist with routine communications and document requests to clinical trial sites, CROs, and vendors, with guidance from Clinical Operations colleagues.
- Update trackers for site activation, recruitment, study milestones, action items, and other key study information.
- Support data entry, document reconciliation, and other trial-related administrative activities as assigned.
- Prepare meeting agendas, take accurate meeting minutes, maintain action logs, and assist with study status updates.
- Provide administrative support for tracking clinical trial invoices, investigator payments, purchase orders, and vendor documentation, as needed.
- Assist with maintaining Clinical Operations procedures, templates, filing conventions, and team resources.
- Coordinate Clinical Operations team meetings, including scheduling, agenda preparation, meeting materials, minute-taking, and follow-up on action items.
- Manage trial-related correspondence, shared mailboxes, electronic folders, and records in an organized and timely manner.
- Provide general administrative and project coordination support to the Clinical Operations team, as required.
- Support site and study activities as needed, which may occasionally include travel with Clinical Operations colleagues.
- Follow Company Standard Operating Procedures, policies, established processes, and applicable regulatory requirements.
- Complete assigned tasks with a high level of accuracy, attention to detail, and timeliness.
- Work collaboratively with colleagues and ask questions or escalate issues when guidance is needed.
- Identify missing information, inconsistencies, or administrative issues and bring them to the attention of the appropriate team member.
- Communicate clearly, professionally, and proactively with internal and external stakeholders.
- Take ownership of assigned administrative tasks and follow through to completion.
- Contribute positively to a collaborative, supportive, and fast-moving team environment.
Skills and Qualifications
- A degree in a life science, health-related, business, or other relevant discipline is preferred. Relevant administrative, clinical research, healthcare, or office-based experience may be considered in lieu of a degree.
- Excellent administrative and organizational skills, with strong attention to detail and the ability to manage multiple tasks and deadlines.
- Prior experience in clinical research, a CRO, pharmaceutical, biotechnology, healthcare, or another regulated environment is helpful but not required.
- Strong written and verbal communication skills and a professional, responsive approach to working with colleagues and external partners.
- Comfort working with documents, trackers, shared folders, and electronic systems; proficiency with Microsoft Office applications, particularly Word, Excel, Outlook, and Teams.
- A willingness to learn clinical trial processes, GCP requirements, and TMF/document management practices.
- Ability to follow established processes, work reliably with appropriate guidance, and collaborate effectively within a team.
Working Behaviors (Core Expectations)
- Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
- Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
- Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
- Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
- Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.
Why Join Us?
At CellCentric we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.
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