Styker Inari is seeking a Sr. Clinical Safety Specialist to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This is a remote position based anywhere within the United States.
As Sr. Clinical Safety Specialist, you will support the integrity and quality of clinical safety data across a portfolio of clinical studies and registries. This role focuses on consistent evaluation, documentation, and reporting of adverse events in alignment with global requirements while collaborating across study teams and external partners. You will contribute to the execution of safety processes throughout the clinical study lifecycle.
What you will do
Review adverse events, serious adverse events, and endpoint-related events across clinical studies to ensure accurate assessment and documentation.
Prepare clinical safety narratives using source documents and study data, completing deliverables within defined timelines and quality standards.
Collaborate with clinical sites and monitors to request, collect, and verify source documentation required for adjudication.
Apply MedDRA coding to adverse events to ensure standardized classification and consistency across studies.
Coordinate with study teams, medical monitors, and adjudication committees to support protocol-aligned safety reviews.
Contribute to safety management plans for assigned protocols and support safety review meetings with documented findings.
Monitor safety data quality by identifying discrepancies and implementing corrective actions to maintain completeness and accuracy.
Maintain compliance with Good Clinical Practice and regulatory requirements through adherence to standard operating procedures and audit readiness.
What you need
Required
Bachelor’s degree
2+ years of clinical research experience
Experience applying Good Clinical Practice standards in clinical trials
Proficient with electronic databases used for clinical trials such as, Zelta, etc.
Preferred
Bachelor's degree in life science or related field
2-4 years of experience in medical device clinical trials
Experience with adverse event review, safety reporting, or pharmacovigilance processes
Knowledge of MedDRA coding standards
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
United States of America Pay Ranges:
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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