Clinical Research Associate

Description:

Why join Stryker? Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. Job description We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Join our Clinical Research team and contribute to pioneering research that advances patient outcomes and transforms healthcare! Our Clinical Research Associate will support studies aimed at assessing clinical safety and effectiveness. In this crucial position, you will ensure that studies are properly designed, coordinated, executed, and analysed to deliver the highest level of scientific evidence and most effective outcomes. This role plays a vital part in providing both exceptional customer service and scientific credibility to the business. Key areas of accountability:

• Prepare documentation required for Research Review Proposals and HCP committee meetings
• Reviews & implements trial protocols
• Coordinate communication with the ethics committee and study sites
• Assists with drafting of contracts for IIS, SCS and SIS studies or other associated governance documentation
• Design the layout for data collection forms (CRFs)
• Assist with setting up study sites, monitoring trials & closing down study sites
• Training of and liaison with clinical study personnel at study sites
• Collects completed CRFs from hospitals and general practices
• Verify data (source data/document verification)
• Prepare site monitoring visit reports
• Completes data entry and database maintenance
• Assist with data analysis for Stryker Collaborative and Sponsored studies as well as Regulatory requirements
• Assist with abstract writing and presentation slides for scientific meetings and podium presentations. Provides clinical summaries as required.
• Assist with communication of trial activities to internal stakeholders including marketing, RAQA, legal and Operations.
• As a Clinical Partner, hold regular update meetings and information sessions with marketing divisions on clinical studies.

Critical Requirements (eg: skills, experience, qualifications):

• Tertiary qualifications in engineering, medical sciences, bioengineering or similar clinical or medical device related area, with a significant element of experimental design, data analysis and presentation are essential.
• A minimum of 1-2 years’ experience of clinical trial administration and management.
• A proven ability to manage within a team and coordinate activities of people in an organised and logical fashion.
• Ability to use initiative and work toward established goals with a minimum of ongoing guidance and direction.
• A high level of both verbal and written communication skills.
• A demonstrated ability to communicate and interact with data / clinical personnel and surgeons.

Desirable Requirements (eg: skills, experience, qualifications):

• Engineering and medical device experience is desirable, but not essential.
• Travel within Australia and New Zealand to monitor sites.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.