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SalaryWhy join Stryker?
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We are currently seeking a Senior Clinical Research Specialist to join our Medical Division based hybrid in Redmond, WA Monday through Wednesday, remote Thursday and Friday.
Who we want
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
What you will do
As the Senior Clinical Research Specialist, you will work to satisfy applicable regulatory standards and Stryker internal requirements for worldwide Clinical Studies and feasibility research. You will perform assigned Clinical Study management and monitoring activities based on the project’s need.
Conduct pre-market and post-market studies including site support, collection of regulatory documents, IRB submissions, and management of Trial Master Files in accordance with operating procedures and all applicable regulations.
Prepare technical documentation including study protocols, informed consents, case report forms, and study training documents.
Writes the monitoring plan. Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents. Reviews clinical data/information and oversees data correction. Assists in providing interim and final reports and presentations.
Implement strategies for enrollment to ensure timely completion of clinical studies.
Maintains and updates Clinical Research work instructions and quality procedures to ensure compliance with regulatory requirements.
Supports the implementation of new clinical systems/processes as needed.
Support implementation post market clinical evidence strategies to support EU MDR
Provide input to technical documentations such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Summary of Safety and Clinical performance (SSCP).
Maintains a high level of professional expertise through familiarity with scientific literature and product portfolio.
Assists in writing clinical reports, abstracts and journal papers.
What you need
Bachelor’s degree required, preferably in biological sciences or related medical/scientific field.
Minimum 2 years of work experience directly supporting Clinical Research or similar experience in a medical/scientific area required.
Working knowledge of GCP/ICH guidelines, federal and local regulations required.
Proficient knowledge of medical terminology required.
Knowledge of clinical and outcomes research study design required.
Global clinical trial experience and EUMDR working knowledge preferred.
Academy of Clinical Research Professionals Clinical Research Associate certification preferred.
$86,600.00- $138,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
About Stryker
Our benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
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. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Know someone at Stryker?
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
