Clinical Trial Specialist (Hybrid)
Stryker Neurovascular is seeking a Clinical Trial Specialist to be based hybrid two to three days per week in Fremont, CA.
Who we want
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
What you will do
As the Clinical Trial Specialist (Hybrid), you will work closely with Program Management to delivery high quality site monitoring and management for the Study Operations team within Clinical Shared Services. This will include clinical operations activities through the coordination of our global Clinical staff or within a geographic region.
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 that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);
Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);
Verify Investigational Product accountability;
Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);
Conduct routine monitoring visits on behalf of the clinical trial sponsor.
Prepare manual of operations for study sites
Prepare informed consent documents
Completes clinical project deliverables per schedule
Ensures audit-readiness
Communicates relevant information to the PM/LCTS in a timely manner
Contacts sites on a consistent basis to assess study compliance
Identify and address noncompliance issues at investigative sites, assist CTS with CAPA, if necessary
Tracks Screening & Enrollment and identify issues and propose solutions.
Independently confirms that site documents match Study Master File
Participates in the conduct and training at Investigator Meetings.
Maintains expertise in regulations for all geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
Generates status reports, oversees process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
Collects and tracks regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study/project annual reports and financial disclosures) to/from study sites using company specific database
Reviews and collects documents to compile Clinical Events Committee (CEC) packets for CEC adjudication meetings
Assembles and tracks metrics data.
Mentors and trains CTCs
Recommends process improvements to increase team efficiencies and effectiveness.
Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements
What you need
Bachelor’s Degree required, preferably in a health science field
2+ years medical industry experience or equivalent (device, pharmaceutical, biotechnology)
Previous experience with regulated global trials preferred
Excellent teamwork and collaboration skills
Ability to travel up to 40%
$97,900.00- $156,900.00salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.