Hybrid Clinical Trial Assistant (Entry-Level)

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

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.