• Job Description

  Req#: R523893
  Work Flexibility: 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 - $156,900.00 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: 40%

  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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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