Avania are hiring for the key role of experienced Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA) As a CRA/Sr CRA you will be the lead for several studies running in parallel, in all associated clinical trial phases, from regulatory submissions to close out visits, from site management to sponsor management As a CRA/Sr CRA you will: + Be responsible for the start-up and initiation of Clinical Investigations including application processes to ethics committees and national competent authorities, preparation and conduct of site monitoring, site management and close out activities. + Be the study lead for several studies. + Act as main point of contact for the sponsor. + Manage small clinical Investigations independently. + Ensure coordination of a larger Clinical Investigations in collaboration with other CRAs and contractors together with a Project Manager. + Train study sites on performing Clinical Investigations. + Identify problems and risks that interfere with project progress, implement strategies to resolve issues in cooperation of a Project Manager. Work on site-level to ensure timely resolution of issues found during visits. + Organize and actively participate in sponsor, investigator and project meetings. + Provide consistent reports and updates to all team members and management (in team meetings) by keeping the Project Manager informed and assist Project Manager in managing the project. + Be involved in Task Forces and may obtain special initiatives such as acting as a ‘Subject Matter Expert’. Working for Avania is working in a diverse environment; from performing fist in human pivotal studies to post market studies, with start-ups to multinationals. All within a broad spectrum of diverse medical devices, IVDs, biologics, and device-drug combination products, internationally with a customized approach Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply to our CRA/Sr CRA role. With our continued growth we are hiring talent to join us on our journey and grow with us. We seek - + Life sciences master’s degree, scientific or nursing discipline and or training/experience. + 3 + years of relevant work experience as a clinical research associate – CRA. + Attention to detail. + Team player. + Excellent communication skills and the ability to train people. + Knowledge of ISO14155 and/ or ICH-GCP-E6. + Ability to travel domestically. + Proficient in the use of computer and software systems. Benefits of Joining Avania in the APAC region: + Opportunity to be involved in novel cutting edge device clinical trials. + Ongoing development and regular training opportunities. + A diverse, experienced, supportive, and collaborative team. + Competitive compensation and benefits package (details shared during the interview process). + Ability to forge your own career path in which you will never be treated as a number. + Team events and full team meetings. + Working in the APAC region but part of a global company that is growing. + Fast tracked promotion pathways for exceptional performance and employee engagement. + We combine scientific medical device leadership and global operational excellence with vast experience. As we believe that collaboration yields the best results, we value team spirit. Inhouse training activities are organized each year in order to share knowledge, build on open communication and comradery. We offer a full range of clinical trial services in the Asia Pacific region as part of a Global Company, and we have offices in Melbourne and Sydney and offer flexible work options throughout Australia and New Zealand. When you need to advance your career, it takes Avania! #LI-DNI