Clinical Research Associate 2
$120,000–$145,000 year
Hybrid · Fremont, California, United States
Job Summary
The Clinical Research Associate is responsible for managing clinical operations projects, focusing on biospecimen management, GCP documentation, and compliance for clinical research studies. The role requires expertise in oncology molecular testing and Next Generation Sequencing (NGS) platforms. Key responsibilities include leading clinical operations activities, managing study operations with CROs, overseeing clinical site activities, and ensuring adherence to quality standards. Candidates must possess a BS or MS in a related field and have at least 2 years of relevant industry experience.
Required Qualifications
- BS or MS in biological science, computer science or a related field
- Minimum of 2+ years working in industry or academics in clinical operations for medical devices
- Experienced with products in a clinical or regulated environment (such as with IRB, FDA, CAP/CLIA etc)
- Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) organization and structure
- Experience with Onsite or Remote clinical study monitoring
- Experience with Case Report Form (CRF) creation
- Proficiency in MS Word, Excel, and PowerPoint
- Experience with Good Clinical Practice (GCP) and clinical quality compliance
- Demonstrated history of successfully managing multiple concurrent initiatives
- Strong interpersonal skills, collaboration, and problem-solving with colleagues
- Strong communication and excellent written and oral skills
- Detail-oriented, with solid organization and time management skills
- Able to work under pressure, self-starter, and team player
Desired Qualifications
- 3+ years working in industry or academics in clinical operations for medical devices
- 2+ years program management experience
- Experienced with products for ex-US regulatory agencies (EU, Japan, Australis etc)
- Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) setup and validation
- Experience in Metadata Statistical analysis
Additional Requirements
- Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities
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