Senior Clinical Research Specialist (Hybrid) - Washington, Redmond 11811 Willows Rd Ne

Work Flexibility: Hybrid

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.

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.