Clinical Trial Assistant

Bayside Solutions; Fremont (CA); Hybrid; USD 93,600 - 114,400; Full time

Job summary

A leading life sciences staffing firm is seeking an entry-level Clinical Trial Assistant to provide crucial operational support for clinical studies. In this hybrid role, you will assist with document management and compliance under the supervision of a Clinical Program Manager. Ideal candidates should possess a relevant degree and some experience in the biotech or pharmaceutical industry. This position also offers a competitive salary range and contributes to significant FDA-regulated operations.

Qualifications

• 0-3 years of relevant experience in the pharmaceutical or biotech industry.
• Familiar with Phase I Healthy Volunteer studies and documentation management.
• Basic understanding of FDA and EMA Regulations and ICH guidelines.

Responsibilities

• Provide administrative and operational support for clinical studies.
• File study documents to the Trial Master File (TMF) and maintain TMF.
• Support development of RCR packs for Phase I studies.

Skills

Clinical Operations

Clinical Research

Oncology

FDA Regulations

Microsoft Office

Education

BS, BA, or RN in a relevant scientific discipline

Tools

eTMF

EDC

CTMS

SmartSheet

Job description

This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $55.00/hr

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.

Desired Skills and Experience

Clinical Operations, Clinical Research, Oncology, Phase I studies, Healthy Volunteer studies, FDA Regulations, EMA Regulations, ICH guidelines, GCP, SOPs, CSET, Regulatory Compliance Review, Microsoft Office, Trial Master File, eTMF, EDC, IRT, CTMS, SmartSheet, travel

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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Seniority level

Mid-Senior level

Employment type

Contract

Job function

Research and Science