Senior Staff Clinical Research Associate

Stryker • Fremont, CA

18d • Remote

About The Position

We are currently seeking a Senior Staff Clinical Research Associate to join our Neurovascular Division . This position is remote based anywhere within the United States. As the Senior Staff Clinical Research Associate (CRA) , you will serve as a senior‑level expert responsible for leading, executing, and supporting complex clinical studies across all phases, including IDE, pre‑approval, post‑approval, post‑market, feasibility, and investigator‑initiated research. This role functions as the primary liaison with investigational sites and investigators, ensuring protocol adherence, regulatory compliance, high‑quality data, and operational excellence. The Senior Staff CRA also provides mentorship, site management leadership, and guidance to the broader clinical team while driving initiatives that support strategic research goals.

Requirements

• Bachelor’s degree in a science or healthcare‑related field
• Minimum 6 years of relevant clinical research experience, specifically including monitoring experience
• Strong knowledge of Good Clinical Practice (GCP), the clinical study development process, and clinical research logistics
• Demonstrated independence in site monitoring (selection, initiation, interim monitoring, close‑out) and site management
• Ability to apply ISO, FDA, and related guidelines to documentation and clinical conduct
• Strong interpersonal, written, verbal communication, organizational, and planning skills
• Proficiency with desktop office applications and electronic systems used in clinical research
• Ability to understand scientific and health‑related concepts and analyze clinical data effectively

Nice To Haves

• CCRA (Certified Clinical Research Associate) certification
• Previous experience as a Clinical Research Coordinator (CRC), Clinical Trial Coordinator (CTC), or Clinical Research Associate (CRA)
• Experience working on international clinical studies or cross‑functional global teams
• Team‑based work experience with demonstrated ability to collaborate across functions

Responsibilities

• Serve as the primary point of contact for assigned investigational sites and manage all phases of site activity—including selection, initiation, monitoring, and close‑out—ensuring compliance with protocol, GCPs, and regulatory requirements.
• Lead and execute clinical studies, including development of protocols, study plans, source documents, informed consent forms, and case report forms.
• Monitor study progress by tracking regulatory submissions, approvals, enrollment, data entry, data quality, and resolution of discrepancies; maintain complete and accurate site documentation.
• Coordinate and oversee key operational aspects such as contracting, auditing, clinical inventory, and regulatory/clinical file maintenance.
• Evaluate clinical data, identify risks or issues proactively, and independently manage or escalate site‑level challenges to ensure timely resolution.
• Prepare high‑quality written monitoring reports and follow‑up communications in alignment with SOPs and monitoring plans.
• Provide mentorship, guidance, and training to CRAs and other clinical team members, contributing to high performance and consistent study execution.
• Participate in internal and external audits and maintain strong clinical and scientific expertise through literature review and engagement with cross‑functional project teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level