Clinical Research Associate
Hybrid (Alameda, CA)$120k - $145kFull-timePosted 2w ago
About the role
Clinical Research Associate responsible for start-up, monitoring, and close-out of US-based clinical trials to ensure subject safety and data integrity, acting as the primary contact between the company and clinical sites. Ensures compliance with study protocol, FDA regulations, ISO 14155, and internal SOPs; demonstrates proactive process improvement and ownership mentality.
Responsibilities
- Organize study start-up and close out materials for US-based clinical studies.
- Conduct the full cycle of site visits, including Pre-study Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits.
- Perform rigorous review of source documents to ensure data reported on paper case report forms and/or in the Electronic Data Capture (EDC) system is accurate, complete, and verifiable.
- Track and manage the inventory of investigational medical devices at each site, ensuring proper storage, use, and return/disposal.
- Ensure that all Adverse Events and Serious Adverse Events are identified, documented, and reported within the required FDA and IRB timelines.
- Audit regulatory documentation and maintain Sponsor trial master file (TMF) to ensure all essential documents are current and compliant.
- Educate site staff on the specific nuances of the medical device technology and the requirements of the clinical protocol.
- Coordinate IRB submissions with Sponsor staff and study sites.
- Maintain study and site status databases for internal reporting on study progress.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing (RN), or a related healthcare field.
- 2+ years of direct field monitoring experience, specifically within the medical device industry.
- Familiarity with US FDA 21 CFR Part 812 (Investigational Device Exemptions) and GCP (Good Clinical Practice).
- Proficiency in Clinical Trial Management Systems (CTMS), EDC, and eTMF platforms.
- Strong technical writing skills for the production of clear, concise, and compliant monitoring reports.
- Ability to travel 40% of the time across the United States and occasionally abroad to coordinate with other clinical teams.
- Proven ability to work remotely and manage a complex schedule of site visits and administrative follow-ups.
- A bias toward action - you'd rather propose a fix and iterate than wait for permission
- Genuine curiosity about how clinical trials could work better, not just how they currently do
- Comfort operating outside a narrow lane when the study needs it
- A track record (or strong instinct) for identifying and driving process improvements, not just following them.
Skills
Required:Clinical trial monitoringFDA regulations familiarityCTMS, EDC, eTMF proficiency
Benefits
- Competitive salary and equity.
- Medical, dental, vision, and life insurance.
- Flexible vacation and company-paid holidays.
- Healthy meals and snacks provided for non-remote employees.
- Paid parental, jury duty, bereavement, family care, and medical leave.
- Dependent Care Flexible Spending Account, subsidized by Science.
- Flexible Spending Account.
- 401(k)
Last updated Oct 23, 2026. Interested? Apply on the company site.
About Science Corporation
Transcend the limits of biology
Science Corporation is a clinical-stage medical technology company.
medical technologybrain-computer interfaceneural interfacesvision restorationneurotechnology
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