Clinical Research Associate

2 weeks ago

Sydney, New South Wales, Australia Corin Australia Full time $80,000 - $120,000 per year

Corin Australia is looking for a Clinical Research Associate (CRA) to manage various Clinical Studies within Orthopaedic implants and technology. As a CRA at Corin you will manage your assigned studies in accordance with regulatory guidelines, local regulations and SOPs, including assisting with identifying and assessing investigational sites and Investigators and setting up, initiating, monitoring and closing down studies. The role will be primarily based out of our Pymble office, Sydney.

Key responsibilities will see our CRA:

  • contribute to the development of clinical study protocols, case report forms (CRFs), annual reports and other study materials.
  • assist in identifying/selecting an investigator and to assess the suitability of facilities to use as the clinical study site.
  • be responsible for all study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
  • liaise with investigators and site research teams to prepare the necessary documentation for the Ethics Committee (EC) and to manage any EC questions.
  • coordinate the execution of study agreements.
  • develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocols.
  • identify, evaluate, report and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations.

To be successful in this role you will need to have:

  • Degree level education in life sciences or related field
  • 3-5 years of experience as CRA with proven monitoring experience either with a healthcare company, Clinical Research Organisation (CRO) or hospital/health care provider. Experience in a medical device company, and ideally in Orthopaedics, is preferred.
  • Good computer skills: good knowledge of Microsoft Office including MS Outlook, Word, Excel and Power Point.
  • High attention to detail.
  • Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting.
  • Effective interpersonal skills with ability to work in a team or independently as required.
  • Ability to multi-task and manage priorities with effective organisational and time management skills.
  • Demonstrated flexibility and adaptability.
  • Highly motivated with a proactive approach to learning and problem solving.
  • Ability to travel up to 30%, depending on the stage and needs of the clinical study.

What's in it for me?

In return we will offer you a competitive remuneration and benefits package, opportunities for growth and development, within a dynamic, successful and supportive team environment.  At Corin we believe that to be successful at work, you need to enjoy what you do. You have to be rewarded for your efforts and motivated to keep going even when the pressure's on. We will help you to play to your strengths and develop and build a career you can be proud of.   We also recognize that we are living and working in a constantly changing, fast-paced world and we are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

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