Mixed methods UXR *Mountain View, CA / Hybrid*
Artech Information Systems LLC
Clinical Research Assistant
Duration: 12 months (potential to renew annually) Location: Mountain View, CA (onsite) Pay rate: $25-$30/hr. W2 with benefits
We are seeking a detail-oriented Clinical Research Assistant to support our clinical operations. This role is a hybrid of specialized ophthalmic order management and clinical trial documentation. You will work directly with our Lead Clinical Coordinator to ensure the precision of prescription (Rx) lens data, manage specialized inventory, and maintain rigorous study documentation in compliance with regulatory standards.
Key Responsibilities
- Accurately input complex prescription lens data into ordering systems.
- Verify lens parameters
- Communicate with optical labs to troubleshoot order delays or specification discrepancies.
- Verify incoming lenses
- Maintain a real-time tracking log of all pending, shipped, and received lens orders.
- Device accountability: Manage physical and digital inventory of frames and lenses
- Conduct regular audits to ensure inventory levels align with study recruitment targets.
- Support the Lead Coordinator in maintaining the Trial Master File (TMF) and site-specific regulatory binders.
- Assist in the preparation and filing of IRB (Institutional Review Board) submissions, amendments, and continuing reviews.
- Data entry, data collection, and query resolution
- Ensure all participant "Source Documentation" is accurate, legible, and compliant with ALCOA+ principles.
- Facilitate the Informed Consent process for study participants, ensuring all ethical and regulatory requirements are met.
- Adhere strictly to GCP (Good Clinical Practice) and HIPAA guidelines regarding participant privacy and data integrity.
Required Qualifications
- Minimum of 1 year of experience in clinical research or similar regulatory role.
- Proven experience working with IRBs, managing the consenting process, and maintaining clinical study documentation.
- High level of comfort with data entry where precision is critical (familiarity with ophthalmic prescriptions is a plus).
- Exceptional tracking skills; ability to manage high volumes of hardware/inventory without loss of data integrity.
- Strong professional presence for participant interaction and clear technical communication with lab partners.
- GCP certification
Preferred Skills
- Familiarity with optical and ophthalmic terminology
- Previous experience in a device-based clinical trial environment
Vacancy posted 2 days ago
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