Clinical Trial Specialist

1 week ago

Fremont, California, United States Stryker Employment Company, LLC Full time
Work Flexibility: Hybrid

We are currently seeking a Clinical Trial Specialist to join our Neurovascular division. This is a hybrid position based 2-3 days per week at Stryker Neurovascular headquarters in Fremont, CA.

Who we want

  Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As the Clinical Trial Specialist , you will manage study start up activities for clinical trial sites, train site staff, manage Investigational Product (IP) and develop trial materials. You will establish site relationships and manage the monitoring activities of assigned clinical trials to ensure data integrity and adherence to federal regulations.

Manage data, conduct routine site visits, ensure timely reporting of adverse events, generate, and distribute internal and external communication.

Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, Good Clinical Practices, and regulatory requirements

Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC

Verify data in the Case Report Forms against source documents

Review accuracy and completeness of site records

Verify IP accountability

Conduct routine monitoring visits

Prepare informed consent documents

Completes clinical project deliverables per schedule

Ensure audit-readiness

Communicate relevant information to the PM/LCTS in a timely manner

Contact sites on a consistent basis to assess study compliance

Identify and address noncompliance issues at investigative sites

Track Screening & Enrollment and identify issues and propose solutions

Collect and track regulatory documents

What you need

Bachelor's Degree required

2+ years of clinical research experience as a Clinical Research Coordinator, Clinical Trial Coordinator, or Clinical Research Associate

Medical device industry a plus

Knowledge of GCP/ICH guidelines

Knowledge of medical terminology 

Knowledge of FDA regulations and their practical implementation 

Ability to travel extensively (up to 50%)

$97,900 - $156,900salary 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: 50%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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