Clinical Research Associate
New Jersey, United States /
Clinical Research /
Note: We support remote working for this role to be based anywhere within the US. #LI-Remote #LI-KE
Why join us?
💜 Do work that matters. We’re pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day.
🌏 Well-funded and global. annalise.ai has a global presence across APAC, EU and US regions. We’re backed by I-MED radiology and harrison.ai (raised Australia’s largest Series B of $129m in 2021).
🌟 Work with a bunch of awesome, genuine people who are passionate about what they do.
💻 Flexible and remote-friendly working
🚀 Make an impact. You won’t be another ‘cog in the wheel’ here. We give full trust and autonomy for you to be heard, to work on big & complex projects – and to make a real difference.
🌱 Grow your career with us. We’re big believers in lifelong learning. You’ll be given a $1000 personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career.
🙌 Generous parental support including 16 weeks gender-neutral paid parental leave and $10,000 support for egg or sperm freezing.
🌈 Do your best work and have fun doing it with unlimited well-being leave, monthly meditations, inclusive team events, and lots more!
About your role
As a Clinical Research Associate at annalise.ai, you will play a vital role in the generation of clinical evidence to support software as medical device (SaMD) artificial intelligence (AI) products used in diagnostic medical imaging. Our focus is conducting studies and delivery of clinical evaluation (or other regulatory submission) activities and documentation in accordance with all applicable standards and regulations to produce quality clinical evidence supporting the regulatory and marketing strategy for annalise.ai products.
You will manage the end-to-end conduct of clinical and non-clinical performance studies evaluating SaMD AI products within the functional role of Study Manager for assigned studies. This is an excellent opportunity to learn to conduct clinical and non-clinical performance studies evaluating SaMD within the growing field of artificial intelligence.
Your accountabilities will be spread across study management and clinical evaluation activities (planning, reporting, literature reviews and post market clinical follow up). You will manage the development of study, clinical evaluation and/or performance evaluation documentation (with cross functional input) to support regulatory submissions.
What you'll do:
- Manage the planning and timely execution of assigned studies;
- Monitor, appropriately communicate and manage risk of assigned studies;
- Develop key study documents (e.g. study protocols, ethics submissions, study plans and study reports) with cross functional input;
- Assist with SOP development and maintenance as required;
- Provide cross functional review of clinical evaluation or other regulatory documentation such as clinical evaluation plans and reports, post market follow-up plans and reports and literature review protocols, performance evaluation summaries and clinical evaluation reports; and
- Conduct or assist with literature reviews, manuscript submissions and conference abstracts.
What will help you succeed:
- Experience working within the medical device industry;
- Experience working within the field of clinical research;
- Bachelor’s degree in a relevant field (e.g., nursing, life sciences or medical science); and
- Strong understanding of ICH/GCP, ISO14155 2020, 2017/745 (EU MDR), 21 CFR
Nice to have (but not essential):
- Experience with medical device regulatory submissions, especially for US FDA;
- Experience working in research involving artificial intelligence, SaMD and/or medical imaging;
- Experience with medical and/or technical writing, to include state of the art and literature summaries;
- Experience performing statistical analysis and/or programming expertise; and
- PhD and/or post-graduate qualification in a relevant area of medical science.
What we’re about
We're problem solvers, redefining what’s possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day.
Yes, we’re a technology company and yes, we’re leveraging the latest AI technologies, but people are at the heart of everything we do.
annalise.ai was formed in early 2019 through a unique partnership between harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Since then, we’ve scaled rapidly and we’re focused on creating AI solutions that help radiologists diagnose medical images.
Our first product, the world's most comprehensive AI clinical decision-support solution for chest x-rays, is already in made available to 1 in 4 radiologists in Australia and rolling out to hundreds more. This solution is capable of detecting 124 findings and was recently featured in peer-reviewed publication, Lancet Digital Health journal.
And we’re just getting started.
Help us shape the future of AI in medical imaging. And most importantly, help us make a real difference in people’s lives.
If you’re inspired by what we're up to, please apply now and we'll be in touch soon.
We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. That’s why we’re committed to building inclusive teams that represent a variety of backgrounds and skills. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, just contact us at accommodations: email@example.com. We look forward to hearing from you.