Clinical Trial Specialist (Hybrid)

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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 - $156,900 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.

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.

Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.