Clinical Trial Assistant

Clinical Trial Assistant

W2 Contract-to-Hire

Salary Range: $93,600 - $114,400 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

This role 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 Clinical Program Manager, you will play a critical role in executing well-defined tasks that support the startup, maintenance, and close-out of clinical studies.

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.
• 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.
• Create, maintain, and manage TMF Study Plans and ensure filing compliance across internal and vendor teams.
• Collaborate with vendors to support ongoing TMF and operational deliverables, ensuring consistency across all study documentation.
• Maintain study training matrices and submit finalized records to ComplianceWire to ensure ongoing inspection readiness.
• Maintain study trackers, including but not limited to CSET Team Member lists, Master Study Metrics Tracker, Vendor Contact List, and other key operational trackers to support cross-functional visibility.
• Support development and maintenance of RCR (Regulatory Compliance Review) packs for Phase I Healthy Volunteer studies to ensure completeness and readiness for sponsor and regulatory review.
• 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.
• 0-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
• Familiar with Phase I Healthy Volunteer studies, including study startup, document management, and coordination of cross-functional deliverables.
• 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, SmartSheet).
• Oncology & Phase 1 Healthy Volunteer Study experience preferred.

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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