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Job description
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.