Stryker Corporation is looking to advance clinical research that improves patient outcomes by supporting critical studies from start-up through close-out, ensuring accuracy and compliance.
Requirements
- Fundamental knowledge of Good Clinical Practices (GCP), clinical study development processes, and logistics.
- Knowledge of clinical and regulatory affairs.
- Experience in a related field (e.g., medical or research) and familiarity with medical terminology.
- Licensed/certified healthcare training
Responsibilities
- Manage clinical documents and upload them into the Product Lifecycle Management (PLM) system.
- Track inventory and reconcile study and demo devices across sites.
- Create and maintain study trackers and lists; assist with mass mailings.
- Upload acquisitions into the Clinical Trial Management System (CTMS) and maintain Trial Master File (TMF) in inspection-ready state.
- Communicate with assigned sites to collect and review essential documents; perform quality control reviews and resolve issues.
- Support development and maintenance of study documents and templates to ensure data integrity and compliance with federal regulations and company policies.
- Distribute, collect, and track project-specific training documentation within established timelines.
Other
- Candidates must reside within a commutable distance to Fremont, CA and be able to work onsite several times per week.
- Bachelor’s degree
- Travel Percentage: Up to 25%
