Clinical Study Associate

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by responding in innovative ways to the needs of our global customers and patients. We have created a work environment that attracts talented, driven people who love to win and to serve others. We hold ourselves accountable to reach or exceed our goals and to continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together. They are the foundation of all we do. And they are the enablers of both our past and future success.Stryker is one of the world’s leading medical technology companies with the most broadly-based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. The Company's website address is http://www.stryker.com

JOB DESCRIPTION:
Assists the Clinical Study Manager (CSM) in the development and implementation of clinical studies, including Investigational Device Exemption, post-approval, post-market surveillance, feasibility and/or marketing studies. Also 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.Perform center activation tracking, ensuring receipt of proper study documentation.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.Assist the CSM with site visits and training of site personnel.Perform investigational device tracking process.Coordinate pre and post-monitoring activities for monitors.Review completed CRFs for consistency and produce queries to site for corrections.Assist CSM with periodic mailings to sites for data issues and study communication.Serve as liaison between clinical personnel, site personnel, and Stryker field personnel.Set up filing, documentation management and tracking systems.Perform periodic quality control of clinical study files and resolve findings.Assists CSM with study closure activities.Support CSM in development and maintenance of study records.Support CSM in preparation and maintenance of patient recruitment and retention strategies.Support CSM on data management functions including SAS reports, review of program specifications, User Acceptance Test and edit checks approval.Develop, distribute and prepare monitoring plan and visit materials.Prepare training materials for clinical studies.Review monitoring visit reports and follow up on observations.Perform monitoring and co-monitoring as required.Review adverse events forms and report observations to CSM.Process and track Investigator payments and patient reimbursements.May execute parts or all of the filing process. Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics' Continual Improvement initiative.Basic knowledge and experience with Clinical Research either from an investigative site, Institutional Review Board (IRB), or sponsorApplied knowledge of Good Clinical Practices (GCPs)Demonstrated interpersonal, written and oral communication skills.Demonstrated organization and planning skills.Team-based work experience preferred.Applied knowledge of personal computer systems and desktop office applications
EDUCATION:
Associates degree in a health sciences and/or business related field PLUS 2-4 years experience in clinical study administration or related field.
OR
Bachelor s degree in health science or technical discipline PLUS 0-3 years experience in clinical study administration or related field.Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce.To read more about Stryker, please visit our website at www.stryker.com