Hybrid Clinical Trial Assistant - TMF & Ops Support

Bayside Solutions, Inc.; California; Hybrid; USD 93,600 - 114,400; Full time

Job summary

A healthcare staffing agency is seeking a Clinical Trial Assistant for a hybrid role in California. This entry-level position offers an opportunity to support clinical trials through administrative duties. Responsibilities include managing trial documentation, coordinating meetings, and ensuring compliance with regulatory standards. Candidates should have a relevant degree and 0-3 years of experience in clinical operations or research. A proactive, detail-oriented approach is essential.

Qualifications

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

Responsibilities

• Provide administrative support for clinical studies under supervision.
• Coordinate meeting agendas and logistical support for the Clinical Study Execution Team.
• Manage and maintain the Trial Master File.

Skills

Clinical Operations

Clinical Research

Oncology

Basic organization skills

Basic communication skills

Proficient in MS Office

Regulatory Compliance Review

Education

BS/BA/RN in a relevant scientific discipline

Tools

MS Office

eTMF

EDC

IRT

CTMS

SmartSheet

Job description

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