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 Senior Clinical Research Associate to join our Neurovascular Division to be in the following locations: Fremont, CA, Colorado, Texas, Florida, New York, Pennsylvania, New Jersey, North Carolina, South Carolina, Virginia, Massachusetts.
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 2016 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.
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.
Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do
As the Senior Clinical Research Associate you will independently support planning, preparation, execution, control/monitoring and closeout of clinical trials. You will establish cross-functional and KOL relationships. You will demonstrate the ability to independently handle clinical trials. 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 supporting and complying with applicable Regulations, ICH/GCP principles and Stryker SOPs in the timely completion of complex global neurovascular studies.
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.
Complete clinical project deliverables per schedule.
Communicate relevant information to the PM/LCRA in a timely manner.
Contact sites on a consistent basis to assess study compliance.
Identify and address noncompliance issues at investigative sites, assist Sr. CRA with CAPA, if necessary.
Track Screening & Enrollment and identify issues and propose solutions.
Independently confirms that site documents match Study Master File.
Participate in the conduct and training at Investigator Meetings.
Maintain expertise in regulations for all geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
Generate 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.
Collect 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.
Review and collects documents to compile Clinical Events Committee (CEC) packets for CEC adjudication meetings.
Assemble and track metrics data.
Mentors and trains CTCs.
Recommend 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 Complete all training requirements on time.
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 2 years of experience in medical device or pharmaceutical clinical trials as a Clinical Research Associate required.
Demonstrated independence in performing site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities 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: Remote
Travel Percentage: 70%
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.