Senior Clinical Trial Assistant

W2 Contract: Part-Time

Pay Range: $45 - $50 per hour

Location: South San Francisco, CA - Hybrid or Remote PST

Job Summary:

As a part-time Senior Clinical Trial Assistant, you will support the study team to ensure the execution of assigned trials according to study timelines and compliance with ICH GCP, country regulations, and SOPs. You will ensure the Trial Master File (TMF) is inspection-ready, assist with onboarding and mentoring CTAs, and contribute to process improvement initiatives.

Duties and Responsibilities:

• Contribute to developing Clinical Operations SOPs, best practices, work instructions, tools, and templates.
• Train and mentor Clinical Trial Assistants.
• Review protocols and amendments for discrepancies and administrative edits (QC review).
• Prepare and update study documents related to protocols and amendments.
• Support the planning, conduct, management, and completion of assigned clinical trials under guidance.
• Schedule meetings and perform related activities.
• Coordinate study team communications, documentation, and correspondence.
• Provide accurate and up-to-date information and study status reports to clinical team members.
• Organize and maintain shared spaces (SharePoint, Teams) for the study team.
• Assist in Clinical Operations activities, including reviewing study plans, manuals, and other essential documents.
• Assist in the development and formatting of study-related documents and spreadsheets.
• Follow the study timeline to meet deadlines for assigned tasks.
• Coordinate new vendor set-up in systems with Finance and Legal and manage purchase order creation and approval. Request Clinical Trial Insurance and guidance from Legal.
• Track training requirements and training completion status for study-specific team training.
• Review, track, and file TMF documents such as informed consent documents, IRB approvals, financial disclosure forms, and other study-related documents for the study team.
• Maintain in-house electronic storage of clinical document archives and TMF.
• Work with TMF document owners to ensure documents are filed and completed according to the TMF plan.
• Assist with periodic QC of the TMF.
• Prepare feasibility survey under guidance.
• Assist in planning and organizing Investigator Meetings.
• Cultivate and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs).
• May perform UAT of CRF in EDC.
• Potentially review CRF Completion guidelines.
• Support IRT access and helpdesk activities.
• Manage submissions and updates of trial information in clinical trial registries.

Requirements and Qualifications:

• Bachelor's degree with 1 - 2 years of relevant experience; direct experience in TMF management is preferred
• Knowledge of clinical trial processes and ICH GCP guidelines.
• Experience filing essential documents according to the DIA reference model.
• Familiarity with using eTMF, EDC, IRT, CTMS, and other vendors systems/portals.
• Clear and concise verbal and written communication skills and strong organizational skills.
• Able to multi-task, prioritize, track projects, and follow through on time with assigned tasks.
• Exceptional attention to detail.
• Able to work independently and in a matrix environment as part of a team.
• Able to learn quickly and effectively using newly acquired skills.
• Willingness to go beyond the scope of the job to help the department and organization achieve objectives.
• Willingness to embrace change and work in a changing environment.
• Able to work collaboratively across cultures and geographies.
• Proficient in Microsoft Outlook, Word, PowerPoint, and Excel.

Desired Skills and Experience

Clinical trials, TMF, eTMF, EDC, IRT, CTMS, SOPs, ICH guidelines, Microsoft Office

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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