Clinical Research, Associate I
$73,900–$116,000 year
On-site · Alameda, California, United States
Job Summary
Clinical Research Associate I responsible for ensuring quality, accuracy, and integrity of clinical trial data across multiple trials per CFR, ICH-GCP, and ISO14155. This on-site role in Alameda, CA involves performing internal clinical studies, recruiting participants, conducting informed consent discussions, recording data, coordinating start-up through close-out, performing study site visits (SQV, SIV, IMV, COV), generating monitoring reports, and supporting regulatory submissions. Must assist with shipping study devices, maintaining Trial Master File/eTMF, and collaborating with study teams and management to communicate study status. Skills include clinical monitoring, site management, data listing reviews, CRF development, SOP adherence, and strong interpersonal/communication abilities; requiring a BS degree in life sciences (or equivalent) and at least 2 years CRA/CRC/CTA experience with familiarity in medical devices or in-vitro diagnostics, CFR/ICH-GCP knowledge, and Microsoft Office proficiency.
Required Qualifications
- BS degree in life sciences preferred or equivalent with minimum 2 years of CRA/CRC/CTA experience
- Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred
- Pharmaceutical background may be considered
- Demonstrated excellence in teamwork and interpersonal/communication skills
- Working knowledge of CFR, ICH-GCP
- Flexibility in daily activities
- Proficient with Microsoft Suite
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