Job Description

Job Title: Clinical Research Associate (CRA) - B

Location: Alameda, CA

Duration: 12 Months

Job Description:

We are seeking a motivated Clinical Research Associate (CRA) - B to join our team and support the successful conduct of Phase I-IV clinical trials. The ideal candidate will be responsible for a wide range of clinical trial activities, ensuring adherence to Federal Regulations, ICH guidelines, and the highest quality standards throughout the study lifecycle.

Key Responsibilities:

• Assist senior staff in planning, executing, and managing clinical studies, including developing study protocols and case report forms (CRFs).
• Support the selection and management of Contract Research Organizations (CROs) and investigator sites.
• Train and evaluate investigator sites, ensuring proper protocol adherence and timely patient enrollment.
• Conduct and oversee study monitoring to ensure data accuracy, compliance, and protocol adherence.
• Manage CRF processing, including data cleanup, classification, and retrieval from study sites.
• Organize and run study meetings, and participate in writing and assembling regulatory submissions.
• Ensure the timely completion of study summary reports and provide support in overall study management.

Qualifications:

• 3-5 years of experience as a Clinical Research Associate, with experience in Phase I-IV clinical trials.
• In-depth knowledge of clinical trial processes, GCP, FDA regulations, and ICH guidelines.
• Strong ability to manage multiple tasks, prioritize effectively, and work collaboratively with cross-functional teams.
• Excellent communication, organizational, and problem-solving skills.
• Proficiency in clinical trial management software and Microsoft Office Suite.

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