Clinical Trial Associate

GQR; United States; Remote; USD 52,000 - 72,000; Full time

Job summary

GQR is seeking a Clinical Trial Assistant to support the execution of early-stage clinical trials in a fast-paced biotechnology setting. You will work with Clinical Operations and cross-functional teams to maintain study documents and ensure trial readiness.

Ideal candidates have a life science degree and 1–2 years of biotech or clinical research experience. This 12-month contract offers remote work from the United States and opportunities to contribute to cutting-edge cancer therapies.

Qualifications

• Bachelor's degree in life science or related discipline required.
• 1–2 years of experience in 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); Smartsheet is a plus.
• Ability to adapt and thrive in a dynamic, fast-growing environment.

Responsibilities

• Support the Clinical Operations team with creation, distribution, filing, maintenance, and archiving of essential clinical trial documents.
• Maintain TMF documentation in an inspection-ready state.
• Assist with development and management of study materials, including training resources, regulatory documents, study plans, manuals, presentations, and communications.
• Coordinate shipments related to clinical trials, including study materials and site supplies.
• Collect, review, and track essential site documents such as CVs, FDA Form 1572s, disclosures, and regulatory packets.
• Communicate with investigative sites, CROs, CRAs, and external vendors to facilitate start-up, 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 minutes, and track action items.
• Contribute to special projects and additional operational activities as assigned.

Skills

Organizational skills

Attention to detail

Independent work

Communication skills

Education

Bachelor's degree in life science or related discipline

Tools

Microsoft Office

Smartsheet

Job description

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.