Clinical Research Associate

•    Clinical Research Assistant

•     Global Medical organisation -  Flexible Work offered

•     North Ryde - 12 month contract, attractive salary package


A well renowned global health care company, is currently looking for an experienced Clinical Research Assistant to join their friendly, collaborative and innovative research team on a 12 month full-time contract with potential to go extend.  The purpose of the role is to support the implementation and start-up of assigned clinical research projects related to specific products/topics according to the internal and external regional requirements, including the acquisition of human use approvals from ethics committees, case report form review, data collection, site monitoring and auditing. Maintain close contact with clinical site coordinators and physicians who are clinical investigators


Role Requirements:

• Assist and conduct clinical monitoring activities such as collecting completed case report forms and collecting, confirming and auditing supporting documentation
• Reporting site enrolment progress including device accountability and enrolment deviations
• Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements;
• Data review, safety reporting and complaint handling
• Document procedural case observations for insights in investigating post procedural events
• Accountable for achieving and reporting on agreed clinical milestones
• Ensures audit readiness for internal and external site audits
• Serve as key contact to assigned clinical sites throughout the study process. Support study team in the interactions with ethics committees and competent authorities
• Close collaboration and internal stakeholders to ensure proper project conduct
• Providing site and personnel training including reparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
• Develop new improved processes and perform implementation

Essential Criteria:

• Previous Clinical Study experience as a CRA is essential and study start up and activation experience will be viewed favourably. Bachelors degree in a related field of study is essential.
• Excellent communication and organisational skills
• Good interpersonal and presentation skills
• Good problem solving and critical thinking skills
• Can work autonomously

If this opportunity sounds like you, please apply now or call Monique Marten on 0431467636 for more information.