Job Description

Role : Clinical Research Associate

Location : Alameda, CA (Onsite)

Duration : 6 Months

Job Description:

Key Responsibilities:

• Monitor and oversee clinical trial sites to ensure timely, accurate, and compliant execution of clinical studies.
• Identify and resolve study-related discrepancies, ensure data integrity, and follow up on corrective actions.
• Maintain study tools, templates, SOPs, and onboarding materials for CRA/site personnel.
• Oversee CROs and vendors for outsourced study activities, ensuring sponsor oversight of study management, monitoring, and data integrity.
• Manage clinical documentation including protocols, Case Report Forms (CRFs), memos, and reports.
• Ensure strict adherence to GCP, SOPs, and regulatory standards across all clinical research activities.
• Train and guide investigators and site coordinators to ensure protocol adherence and regulatory compliance.
• Track and report on site performance, monitoring updates, and escalate risks to leadership when needed.
• Support cross-functional teams, including Quality, Compliance, Product Development, and Engineering.

Qualification:

• Bachelor's degree in Biology, Health Sciences, Mathematics, Computer Science, or related field.
• Hands-on experience in clinical trials, with a clear understanding of monitoring and site management.
• Ability to work independently and proactively identify and resolve issues in a fast-paced environment.
• Creative problem-solving mindset and eagerness to support process improvements.
• Prior CRA onboarding/training experience is a plus.
• CCDM certification is a bonus but not required.

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