Senior Clinical Research Specialist

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

We are currently seeking a Senior Clinical Research Specialist to join our Medical Division to be based in Redmond, WA.

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.

• Other duties as assigned

What you need

• A minimum of a Bachelor’s degree in biological sciences or related medical/scientific field.

• A minimum of 2 years of experience directly supporting clinical research or similar experience in a medical/scientific area required.

You might also have

• Global clinical trial experience and EUMDR working knowledge preferred.

• Working knowledge of GCP/ICH guidelines, federal and local regulations required.

• Medical Device or Pharma experience required.

• Academy of Clinical Research Professionals Clinical Research Associate certification preferred.

• Knowledge of clinical and outcomes research study design required.

• Proficient knowledge of medical terminology required.

• Class III Medical Device, highly regulated environment preferred.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com