Avania are hiring for the key role of Field Clinical Specialist (FCS) and Senior Clinical Research Associate in Device Clinical trials in Australia (FCS / Sr CRA – Dual role)

At Avania our most important asset is our people. We offer an innovative work environment and supportive team culture that values honesty and respects its people. The device trials that we manage are often first in human trials involving novel cutting-edge technologies and our studies are diverse and interesting and can involve any system or region within the human body.

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.

This is a rare and highly sort after career opportunity for the right person.

Field Clinical Specialist role

The role of the Field Clinical Specialist (FCS) is to provide clinical based support of pre and post market clinical... studies including but not limited to serving as a clinical/technical resource for Clients and clinical sites. This role requires excellent multi-level communication skills, an ability to communicate well and be sensitive to investigational participants, as well as establishing and maintaining a good relationship with study investigators and investigational sites. The position involves close and regular communication with Project Managers, other Clinical Research Associates, site staﬀ and Clients in order to provide timely and accurate reporting of clinical events at sites.

The role requires the ability to achieve excellent technical knowledge in a number of clinical areas. The FCS will be responsible for acting as the Client representative in following prescribed Instructions for Use and supporting clinicians during implantation and product related procedures in operating rooms and interventional radiology suites. In a support capacity, this role supports Clients’ research and development in evaluating concepts for new products, and the improvement/modiﬁcations of existing system(s).

As a Field Clinical Specialist (FCS) you:
• Attend implant and study product utilization procedures and follow-ups as needed.
• Assist investigators in product use, training and troubleshooting, only ever in accordance with the approved clinical product and/or instructions for use, but not practice medicine.
• Assist with data acquisition from active implantable devices.
• Submit periodic status reports on ﬁeld-based activities for current open clinical investigations.
• Coordinate closely between Client and Clinical Sites to ensure availability of product and maintenance of order status to ensure accurate inventory status.
• Responsible for inspection of product (as required), packaging of product and transfer of product to investigation sites per agreed implant dates.
• Identify, document and report existing or potential problems (and possible solutions) with products and devices.
• Document problems related to investigational devices and communicate with the Avania Project Manager and delegated Client representatives.

Senior Clinical Research Associate

As a Sr. Clinical Research Associate (Sr CRA) you:
• Are 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 jr. and sr. 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
• Mentor study specific monitoring team, coordinate monitoring activities and conduct co-monitoring or training visits.
• Be involved in Task Forces and may obtain special initiatives such as acting as a ‘Subject Matter Expert’

In project teams the Field Clinical Specialist / Senior Clinical Associate (Sr CRA) role will:
• Make sure that the conduct of the Clinical Investigation is in compliance with the approved protocol, Avania SOPs, GCP/ISO14155, and applicable regulatory requirements.
• Verify that the rights and well-being of human subjects are respected
• Verify that reported clinical investigation data are accurate, complete, and verifiable with source documents

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply to our FCS / 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 in either operating theatres, recovery or intensive care
• 3-7 years of relevant work experience in clinical research (as a clinical research associate) ideally with a Nursing background/qualification
• 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

We look forward to receiving your application!

When you need to advance your career, it takes Avania
Melbourne VIC Australia

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