Stryker Clinical Study Associate in Leesburg, Virginia
COVID-19 vaccination requirements
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, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs (https://careers.stryker.com/covid-19/) page for current vaccination and/or reasonable accommodation requirements and timelines.
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 join our Spine Division. This role will be remote, and candidates can sit anywhere in the United States. This role, however, will be working on east coast business working hours.
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.
• 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.
Assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements. 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. Coordinates the activities of functional groups that comprise the clinical department team for the project including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects. Applies best practices in the development, initiation, planning, execution, control and closing of projects. May also interact with finance, research and development, marketing, manufacturing and regulatory departments as appropriate.
WHAT YOU WILL DO:
• Prepare necessary documents and compile all documentation including regulatory data for the initiation, maintenance, and closure of clinical studies.
• Perform variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research
• Assist the study team in maintaining clinical study documents as well as regulatory documents per sponsor and institutional requirements.
• Assist in performing monitoring visits such as site qualification, initiation, remote monitoring and closeout and complete all required documentation per company and department procedures.
• Process all clinical research payments for research sites, vendors, and suppliers according to established contracts. Develop and maintain tracking of payments, and provide reports on an as-needed basis to management.
• Develop essential document checklist for site assessment, qualification, monitoring and close-out visit activities
• Assist in User Acceptance Testing activities and assist in the drafting and review of Case Report Forms as needed by the study team
• Perform Quality Checks (QC) on study data to ensure completeness, correctness, and compliance to ICH/GCP and data privacy requirements, e.g. HIPAA and GDPR as applicable.
• Under the direction of the study manager, coordinate activities and deliverables with vendors and suppliers, and review them for correctness and compliance.
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
Working knowledge of good clinical practice - preferred
Previous medical device clinical trials experience - preferred
This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.
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/
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