A growing, innovation-driven biotechnology company focused on developing targeted cancer therapies is seeking a Clinical Trial Assistant to support the execution of early-stage clinical trials. This is an excellent opportunity for someone looking to gain hands-on experience within a fast-paced clinical development environment while working alongside cross-functional teams driving cutting-edge research. If you are interested in supporting impactful clinical research and gaining exposure to innovative drug development programs, we’d love to hear from you.

Duration: 12-Month Contract

Position Summary

The Clinical Trial Assistant will provide operational support across one or more clinical studies from start-up through closeout. This role will work closely with Clinical Operations and cross-functional stakeholders to maintain study documentation, support site management activities, coordinate study communications, and ensure clinical trial records remain organized and inspection-ready.

Key Responsibilities

• Support the Clinical Operations team with the creation, distribution, filing, maintenance, and archiving of essential clinical trial documents.
• Maintain Trial Master File (TMF) documentation in an inspection-ready state.
• Assist with the development and management of study materials, including training resources, regulatory documents, study plans, manuals, presentations, and communications.
• Coordinate incoming and outgoing shipments related to clinical trials, including study materials and site supplies.
• Collect, review, and track essential site documents such as investigator CVs, FDA Form 1572s, financial disclosures, and regulatory packets.
• Communicate with investigative sites, CROs, CRAs, and external vendors to facilitate study start-up, ongoing conduct, and closeout activities.
• Assist with investigator meeting planning, preparation, and on-site logistical support as needed.
• Track study team training completion and clinical trial progress metrics.
• Support document review and approval workflows.
• Schedule meetings, prepare agendas, capture meeting minutes, and track action items.
• Contribute to special projects and additional operational activities as assigned.

Qualifications

• Bachelor’s degree in a life science or related discipline required.
• 1 to 2 years of experience within biotechnology, pharmaceutical, clinical research, or healthcare settings.
• Prior experience as a Clinical Research Coordinator or Study Coordinator is highly preferred.
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple priorities and follow projects through to completion.
• Self-motivated, proactive, and comfortable working independently in a remote environment.
• Strong verbal and written communication skills.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); experience with Smartsheet is a plus.
• Ability to adapt and thrive in a dynamic, fast-growing environment.

What We’re Looking For

• A collaborative team player with a strong sense of ownership and accountability.
• Someone who exercises sound judgment and maintains high ethical standards.
• A detail-oriented professional who enjoys supporting clinical trials and contributing to the advancement of innovative therapies.
• An individual who embraces continuous improvement and process optimization.