Note: The job is a remote job and is open to candidates in USA. Stryker is seeking a Senior Internal Clinical Research Associate to support clinical research activities for venous thromboembolism care. The role focuses on operational execution of U.S. clinical studies, site management, study documentation, compliance, vendor coordination, metrics, budgets, and inspection readiness while mentoring junior team members.
Responsibilities
- Lead operational execution of assigned clinical studies while ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
- Serve as a key liaison between internal study teams, field Clinical Research Associates (CRAs), clinical sites, vendors, and external partners to facilitate successful study execution
- Support the development, review, and maintenance of study documentation, including protocols, informed consent forms, monitoring plans, case report forms, and study-related materials
- Oversee Trial Master File (TMF) activities to ensure accuracy, completeness, and inspection readiness
- Develop and maintain study dashboards, trackers, metrics, and reports to support study oversight and decision-making
- Monitor site performance metrics and collaborate with study teams to proactively identify and resolve operational challenges
- Support study budget tracking, site payments, vendor invoicing, and financial reconciliation activities
- Partner cross-functionally with Clinical Program Management, Data Management, Regulatory Affairs, Quality, and Medical Affairs teams to support study objectives
- Contribute to audit and inspection readiness activities and support responses to regulatory requests
- Mentor and provide guidance to junior team members while supporting process improvement initiatives that drive operational excellence
Skills
- * Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related scientific discipline
- * Working knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research processes
- * Experience supporting clinical study operations, study documentation, and trial execution activities
- * Strong organizational, communication, and project management skills
- * Demonstrated ability to manage multiple priorities in a fast-paced environment
- * Minimum of 2+ years of clinical research experience, preferably within a medical device, biotechnology, pharmaceutical, CRO, or sponsor environment
- * Experience supporting U.S. and/or global medical device clinical studies
- * Experience with clinical systems including CTMS, EDC, eTMF, and other clinical trial platforms
- * Experience with study metrics, dashboards, site management, and operational reporting
- * Experience supporting study budgets, site payments, contracts, vendor management, or financial tracking activities
- * Experience supporting audits, inspections, regulatory submissions, or inspection-readiness activities
- * Clinical research certification (SOCRA, ACRP, CCRP, CCRC, or equivalent)
- * Experience mentoring, training, or guiding junior team members
Benefits
- Remote work flexibility
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