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Salary: USD 120,000 - 145,000 / annual
Science is a clinical-stage, vertically integrated technology company developing medical devices to restore vision, cognition, and mobility to patients with debilitating neuroscience conditions. The company also operates Science Foundry, providing state-of-the-art components and infrastructure for others in the industry.
As a Clinical Research Associate, you will serve as the primary point of contact between Science and clinical study sites (hospitals and clinics) for US-based trials. You will be responsible for the full lifecycle of clinical studies—from start-up through monitoring to close-out—ensuring the safety of human subjects and the integrity of clinical data.
Key responsibilities include:
- Organizing study start-up and close-out materials for US-based clinical studies
- Conducting the full cycle of site visits: Pre-study Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits
- Performing rigorous review of source documents to ensure data accuracy, completeness, and verifiability in paper case report forms and Electronic Data Capture (EDC) systems
- Tracking and managing inventory of investigational medical devices at each site, including proper storage, use, and return/disposal
- Identifying, documenting, and reporting Adverse Events and Serious Adverse Events within required FDA and IRB timelines
- Auditing regulatory documentation and maintaining the Sponsor trial master file (TMF) to ensure compliance
- Educating site staff on medical device technology and clinical protocol requirements
- Coordinating IRB submissions with Sponsor staff and study sites
- Maintaining study and site status databases for internal reporting
You will verify that all trial activities comply strictly with the study protocol, FDA regulations, ISO 14155 standards, and internal standard operating procedures. The ideal candidate is proactive, identifies inefficiencies before they become bottlenecks, proposes process improvements independently, and brings an ownership mentality to study success. You should be comfortable working remotely, managing a complex schedule of site visits and administrative follow-ups, and traveling approximately 40% of the time across the United States and occasionally abroad.
Requirements:
- 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 producing clear, concise, and compliant monitoring reports
- Ability to travel 40% of the time across the United States and occasionally abroad
- Proven ability to work remotely and manage a complex schedule
- Bias toward action and comfort operating outside a narrow lane when the study needs it
- Track record or strong instinct for identifying and driving process improvements
Preferred Qualifications:
- CCRA (ACRP) or CCRP (SoCRA) certification
- Experience monitoring Class II or Class III (PMA) medical device trials
- Experience with surgical or operating room (OR) monitoring environments
