Clinical Study Associate

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Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is seeking to hire a Clinical Study Associate to support Joint Replacement Clinical Trials. This role will be based in Mahwah, New Jersey.

WHO WE WANT:

• 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 innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

As the Clinical Study Associate (CSA) you will assist the Clinical Study Manager (CSM) with administrative aspects of clinical studies including Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility and/or marketing studies. This role will be focused on global market access, market adoption and EUMDR for Stryker Joint Replacement products.

The Clinical Study Associate is responsible for ensuring operational aspects of the studies such as documentation, payments and other systems are being conducted in accordance with GCPs, Food and Drug Administration regulations and department Standard Operational Procedures.

• Support Clinical Study Manager in development and maintenance of study records

• Perform center activation tracking ensuring receipt of proper study documentation

• Support Clinical Study Manager in preparation and maintenance of patient recruitment and retention strategies

• Actively participate in the design, development, and testing of the Case Report Forms (CRFs) and database. Work with programmer analyst to set up error checking report and other study reports

• Support Clinical Study Manager on data management functions including SAS reports, review of program specifications, User Acceptance Test and edit checks approval

• Prepare monitoring visit materials

• Prepare training materials for clinical studies

• Assist the Clinical Study Manager with site visits and training of site personnel

• Perform investigational device tracking process

• Coordinate pre and post-monitoring activities for monitors

• Review monitoring visit reports and follow up on observations

• Perform monitoring and co-monitoring as required

• Review completed CRFs for consistency and produce queries to site for corrections

• Review adverse events forms and report observations to Clinical Study Manager

• Assist Clinical Study Manager with periodic mailings to sites for data issues and study communication

• Assist Clinical Study Manager on study development and management activities for assigned studies and/or develop and manage assigned studies

• Assist Clinical Study Manager with and/or manage facilitation of publishing study results in peer reviewed journals

• May identify and support research sites within the region

• Serve as liaison between clinical personnel, site personnel, and Stryker field personnel

• Process and track Investigator payments and patient reimbursements

• Set up filing, documentation management and tracking systems

• Assists Clinical Study Manager with study closure activities

WHAT YOU NEED:

• Bachelor’s degree required. (Bachelor’s degree in science, business, or health-related field preferred)

• 0+ years related work experience required

• 1+ years related clinical trial associate, clinical study associate, clinical research associate or clinical research internship related experience preferred

• Previous medical device clinical trials experience preferred

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com