Stryker ยท 3 hours ago
Clinical Safety Specialist
United States
Full-time
Remote
Entry, Mid Level
$83K/yr - $180K/yr
2+ years expStryker Inari is seeking a Clinical Safety Specialist (Remote) to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role is responsible for maintaining compliance with global safety reporting requirements throughout the clinical study lifecycle and collaborating with various internal and external teams to uphold patient safety standards.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Interact with clinical sites, field monitors to obtain and verify source data for safety event adjudication
Review and code adverse events (AEs), serious adverse events (SAEs), and endpoint-related events using MedDRA, ensuring accuracy and consistency across studies
Write safety narratives and support Safety Review meetings in alignment with the Safety Management Plan and regulatory requirements
Collaborate with Safety Leadership, Adjudicators (Medical Monitors and Clinical Events Committee), and cross-functional teams to develop and execute clinical safety plans
Ensure timely and compliant reporting of AEs/SAEs/UADEs/MAEs while maintaining adherence to SOPs, GCP, and regulatory standards
Drive high-quality safety data collection to support scientific communications, clinical research, and statistical analysis strategies
Proactively identify and resolve potential safety data issues, ensuring clear communication with sites and study teams
Apply strong technical knowledge of products, clinical processes, and disease states to enhance safety oversight and functional excellence
Qualification
Required
Bachelor's degree
Minimum 2 years of experience in clinical research
Proficient with electronic databases used for clinical trials, such as, Zelta, etc
Experience with Good Clinical Practices (GCP)
Preferred
Bachelor's degree in life science
Possesses exceptional attention to detail and strong analytical skills to accurately review CRFs, source documents, and evaluate safety data for quality and compliance
Brings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data integrity
Benefits
Bonus eligible
Benefits
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase