Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Clinical Research Associate to join our Neurovascular Division to be in Fremont, CA.
Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg .
Who we want
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
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.
What you will do
As the Clinical Research Associate you will execute all administrative aspects of study management from start-up through closeout under the guidance and mentorship of senior clinical staff. You will monitor and/or supervise the monitoring activities of assigned clinical trials to ensure data integrity and adherence to Federal regulations, company policies and any other applicable procedures. You will be responsible for conducting the following essential duties with supervision from senior clinical research associates and managers.
Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements.
Identify adverse events from research site staff and under the guidance of Senior CRA ensure appropriate reporting requirements are met.
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.
Conduct routine monitoring visits on behalf of the clinical trial sponsor with Senior CRA oversight as needed.
Prepare sections of the study site manual of operations as delegated by Senior CRA.
Prepare draft informed consent.
Complete delegated clinical project deliverables per schedule.
Assist Senior CRA to ensure audit-readiness of sponsor and investigative site files.
Communicate relevant information to the PM in a timely manner.
Contact sites on a consistent basis to assess study compliance.
Track screening and enrollment and identify/report issues to Senior CRAs.
Confirm that site documents match Study Master Files.
Assist with the organization and administrative support of Investigator Meetings.
Generate status reports process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
Collect and track 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.
Collect documents for Clinical Events Committee (CEC) packets under the supervision of a Senior CRA.
Able to show good judgment with interaction with external customers.
Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements Complete all training requirements on time
Draft, revise and harmonize clinical research forms, questionnaires, trackers and templates.
Manage vendor activities regarding enrollment materials, advertisements and other study-related materials.
Initiate and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training materials, study binders, plans, study registration and other process descriptions, presentations, and reports.
Establish and maintain the CTMF and CTMS; under supervision of the PL and/or CPM review the CTMF/S for compliance, addressing findings as needed and supporting the study team with study activities.
Produce reports and status metrics as requested.
What you need
A minimum of a Bachelor’s Degree (B.S. or B.A.) required preferably with Health Sciences or other related technical discipline or licensed certified health care training required.
A minimum of 1 year of experience in a clinical study administration role required.
Fundamental knowledge and good understanding of GCPs, clinical study development process and logistics required.
Certificate Degree in Clinical Research or CCRA (Certified Clinical Research Associate) credentials preferred.
Work From Home: No
Travel Percentage: 30%
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.