Hybrid CTA - Start-Up to Close-Out in Clinical Trials

Bayside Solutions, Inc.; Santa Clara (CA); Hybrid; USD 93,600 - 114,400; Full time

Job summary

A leading clinical operations firm in the United States is looking for an entry-level Clinical Trial Assistant. In this hybrid role, you will provide vital administrative and operational support across multiple studies. Responsibilities include managing study documents and coordinating with internal and external teams to ensure compliance with clinical regulations. Ideal candidates should have a relevant scientific degree and 0-3 years of experience in the pharmaceutical or biotech industry. A collaborative spirit and basic organizational skills are essential, along with proficiency in MS Office.

Qualifications

• 0-3 years of relevant experience in the pharmaceutical or biotech industry.
• Familiar with Phase I Healthy Volunteer studies and document management.
• Basic understanding of FDA and EMA Regulations, ICH guidelines, and GCP.
• Proficient in MS Office and project tracking tools.
• Demonstrate reliability and proactive communication.

Responsibilities

• Provide administrative and operational support for multiple studies.
• Coordinate CSET meetings and document management.
• File and maintain study documents in the Trial Master File.
• Collaborate with vendors and internal teams on study documentation.
• Support clinical operations activities as appropriate.

Skills

Clinical Operations

Clinical Research

Oncology

Phase I studies

Healthy Volunteer studies

FDA Regulations

EMA Regulations

ICH guidelines

GCP

SOPs

Microsoft Office

Education

BS, BA, or RN in a relevant scientific discipline

Tools

eTMF

EDC

IRT

CTMS

SmartSheet

Job description

A leading clinical operations firm in the United States is looking for an entry-level Clinical Trial Assistant. In this hybrid role, you will provide vital administrative and operational support across multiple studies. Responsibilities include managing study documents and coordinating with internal and external teams to ensure compliance with clinical regulations. Ideal candidates should have a relevant scientific degree and 0-3 years of experience in the pharmaceutical or biotech industry. A collaborative spirit and basic organizational skills are essential, along with proficiency in MS Office.