Clinical Safety Specialist
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Stryker 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. The Clinical Safety Specialist will collaborate closely with internal teamsincluding Safety Clinical Program Management Data Management Biostatistics Scientific Communications and Complaint Handlingas well as external CROs and study partners to uphold the highest standards of patient safety and enable access to advanced care.
What you will do:
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.
What you need:
Required
Bachelors 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
Bachelors 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.
83300.00 to 180400.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Position posted on 1/12/2025
Travel Percentage: 0%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 contractors legal duty to furnish information.Required Experience:
IC
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
