Clinical Trial Assistant, Clinical Operations

Clinical Trial Assistant, Clinical Operations

W2 Contract

Pay Rate: $60 - $65 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant (CTA), you will be responsible for providing administrative and operational support for one or more studies within a clinical program. Reporting to the Associate Director, you will play a critical role in executing well-defined tasks that support clinical study start-up, maintenance, and close-out.

Duties and Responsibilities:

• Work on assignments and problems of limited scope, requiring independent decision-making and initiative, using standard procedures under close supervision.
• Solicit Clinical Study Execution Team (CSET) meeting agenda topics, coordinate meetings, minutes, and logistical support.
• Support site management activities and provide status to CSET (e.g., tracking site documents, distributing study materials, site enrollment metrics, etc.).
• Liaise with internal teams and vendors for document collection and updates; act as primary CTA contact on studies.
• File study documents to the Trial Master File (TMF) and assist with TMF reviews. Maintain TMF and ensure document quality and completeness.
• May assist with protocol amendment documentation and version control.
• May assist with the development of basic department initiatives, process documents, and standard forms most used by CTAs.
• Support other clinical operations activities as appropriate.

Requirements and Qualifications:

• BS, BA, or RN in a relevant scientific discipline.
• 1-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Basic understanding of FDA and EMA Regulations, ICH guidelines, GCP, and familiarity with standard clinical operation procedures (SOPs).
• Basic organization and communication skills.
• Proficient in MS Office (Word, Excel, Outlook) and project tracking tools.
• Demonstrate reliability, proactive communication, and quality in task execution.
• Apply knowledge of Clinical Operations in day-to-day assigned tasks.
• Thrive in a collaborative team setting and be driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Travel may be required (~10%).

Preferred Qualifications

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience preferred.

Desired Skills and Experience

Clinical Operations, Clinical Research, Clinical Trial Assistant, Clinical Study Start-Up, Clinical Study Maintenance, Clinical Study Close-Out, Trial Master File, TMF, eTMF, TMF Review, Document Quality, Document Completeness, Site Management, Site Document Tracking, Study Materials Distribution, Site Enrollment Metrics, Clinical Study Execution Team, CSET, Meeting Coordination, Meeting Minutes, Vendor Management, Vendor Systems, Vendor Portals, EDC, IRT, CTMS, Protocol Amendments, Version Control, FDA Regulations, EMA Regulations, ICH Guidelines, Good Clinical Practice, GCP, Standard Operating Procedures, SOPs, Project Tracking Tools, Microsoft Word, Microsoft Excel, Microsoft Outlook, Cross-Functional Collaboration, Proactive Communication, Task Execution, Oncology, Pharmaceutical Industry, Biotechnology Industry

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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