Clinical Research Associate

Fisher Paykel Healthcare; Auckland; On-site; NZD 70,000 - 110,000; Full time

Benefits offered by this job

Employee share purchase scheme

Bi-annual Profit share

Generous Paid Parental Leave

Life, Critical illness and Income-Prot

Discounted Health Insurance

Active Social clubs & community groups

In-house training programs

Purchasing privileges for Fisher & Pay

School holiday programme subsidy

Banking and Insurance discounts

Free Parking

Beautiful campus with green spaces

Subsidised Cafés

Annual Salary Review

High rates of internal promotion

Access to state-of-the-art facilities

Job summary

Fisher & Paykel Healthcare is seeking a Clinical Research Associate to join our Surgery team in New Zealand. The role involves designing and managing studies across preclinical and clinical stages to build robust evidence supporting product development, as well as contributing to regulatory submissions and clinical education materials.

You will work with a multidisciplinary team, perform literature reviews, identify key evidence, and engage with key opinion leaders to drive clinical

Qualifications

• The ability to search, analyse, and summarise clinical literature.
• The ability to think outside the box and apply scientific knowledge to progress medical device development.
• Understanding of medical device design challenges and how to assess their clinical implications.
• Exceptional oral presentation skills for diverse stakeholders.
• Knowledge of Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) and strong research methodology.
• Experience with clinical research including protocol design, ethics submission, agreements, budgets, and statistics.

Responsibilities

• Help a multi-disciplinary project team to solve challenges and uncertainties by applying physiological knowledge and clinical research.
• Work with the project team to gain understanding of therapy benefits and risks by performing literature searches and sharing information with the team.
• Design and manage studies (preclinical, clinical) at various stages of the project to create an understanding or evidence to support the project objectives.
• Help identify the right clinical evidence for a product/therapy and identify how best to build evidence to support it.
• Identify and build relationships with key opinion leaders to leverage expertise and influence clinical change.
• Support regulatory reviews and submissions.
• Support sales and marketing by developing clinical material, abstracts, posters, manuscripts and presentations to educate customers about benefits and use of products.
• Create and conduct clinical training and education to a variety of audiences.
• Be able to recognise opportunities and do what is required even if it stretches beyond current expertise.

Skills

Literature searches

Clinical research

GCP/GLP

Communication

Team collaboration

Job description

Care to make a difference Join a team of good people doing good work with intent. People like you, who care to make a difference.

Job description

Care to make a difference Join a team of good people doing good work with intent. People like you, who care to make a difference.

About The Opportunity

We are looking for a Clinical Research Associate to join our Surgery team. Our surgery products and therapies provide a wide range of research opportunities from deeper learnings of key clinical outcomes to exploring mechanisms of actions for products under development. Join our driven, innovative team and take the opportunity to learn directly from global clinical experts as we work towards improving the standard of care and improve outcomes of surgery. This is a key role in a multi-disciplinary project team focused on a specific surgery product which is at the very early phases of research and development. You will contribute to the entire life cycle of product development by delivering timely results through understanding the problem, ideation, testing, building evidence, through to commercial release.

You will:

• Help a multi-disciplinary project team to solve challenges and uncertainties by applying physiological knowledge and clinical research.
• Work with the project team to gain understanding of therapy benefits and risks by performing literature searches and sharing information with the team.
• Design and manage studies (preclinical, clinical) at various stages of the project to create an understanding or evidence to support the project objectives.
• Help identify the right clinical evidence for a product/therapy and identify how best to build evidence to support it.
• Identify and build relationships with key opinion leaders to both leverage their expertise to support the project and influence to support driving clinical change.
• Support regulatory reviews and submissions.
• Support sales and marketing by developing clinical material, abstracts, posters, manuscripts and presentations to help educate customers about the benefits and use of our products.
• Create and conduct clinical training and education to a variety of audiences.
• Be able to recognise opportunities and the work to be done then be willing to do what is required even if it stretches you outside of your expertise.

About You

We are looking for someone with:

• The ability to search, analyse, and summarise clinical literature.
• The ability to think outside the box and apply scientific knowledge to progress the development, introduction, adoption and sales growth of medical devices.
• The ability to understand the medical device design challenges and assess their implication on clinical application, and be able to implement a solution together with the product development engineers. It is vital that you are a team player with the ability to interact and communicate with people coming from diverse disciplinary and the openness to learn outside of your immediate area of expertise.
• Exceptional oral presentation skills to a variety of stakeholders.
• Knowledge of Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) and a strong understanding of research methodology.
• Experience with clinical research (including protocol design, ethics submission, agreements, budgets, and statistical analysis).

It would be advantageous if you have:

• Previous experience in hospital operating rooms and surgical procedures.
• Exposure to a commercial environment (or want to learn more in this area).

Working With Us

Care to join a supportive environment? Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work.

• Employee share purchase scheme
• Bi-annual Profit share
• Generous Paid Parental Leave
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance
• Active Social clubs & community groups
• In-house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare and Medela products
• School holiday programme subsidy
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces
• Subsidised Cafés
• Annual Salary Review
• High rates of internal promotion
• Access to state-of-the- art facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

Our commitment to care unites us. Here, we're driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

Care to join us? Apply today

We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at [e-mail]