Senior Associate, Clinical Research at Harrison AI

Clinician, Full-time, Australia full-time
Description
Posted a month ago

Senior Associate, Clinical Research

Note: we support remote work for this role anywhere in Australia.

About us

We are problem solvers driven by a simple desire to do work that matters. We are constantly leveraging the latest medical and cloud computing technologies to build leading Pathology AI solutions with people at the heart of everything we do. As part of our unique Joint Venture structure, we have combined the expertise in clinical artificial intelligence of Harrison AI with the global network and medical diagnostic leadership of Sonic Healthcare, backed by one of Australia’s largest Series B funding rounds ever.

Check out the $129M funding round by Harrison AI:

https://blog.harrison.ai/news/harrison.ai-raises-aud129-million

Established in December 2021, we are here to make a global impact by improving the accuracy and speed of clinical diagnosis in Pathology. To achieve this, we are bringing together an inspiring team of clinicians, data scientists and software engineers to create comprehensive Pathology AI solutions that can scale medical predictions and potentially save millions of lives worldwide.

We are just beginning an exciting journey of greenfield development, and we would love to invite you to join the team!

Why join us?

·       Do work that matters: our pioneering Pathology AI solutions will help detect cancer, improve diagnostic accuracy and potentially save millions of lives.
·       Flexible working: we have a remote-first environment with a cool office for social events and brainstorming sessions, or even full-time onsite if you prefer.
·       Grow your career with us: we are believers in lifelong learning. You’ll have access to a variety of resources and continuous career development opportunities.
·       Competitive salary and equity: we’re constantly analysing market rates to keep our compensation up to date, in addition to offering a generous stock options program.
·       Stay at the top of your game: work with a diverse and collaborative team of industry experts and leaders who are passionate about what they do.
·       Vibrant culture: with sponsored team activities, fun social events and a supportive work environment, your holistic wellbeing is top of mind.

About your role

As a Senior Associate in the Clinical Research Team at Pathology JV you will play a vital role in leading and supporting the delivery of a diverse range of clinical projects evaluating software as medical device (SAMD) artificial intelligence (AI) products in pathology. This role is an exciting opportunity for a highly motivated clinical research professional to join a uniquely talented team. Our team focuses on end-to-end execution of internally conducted machine learning model performance studies and oversight of investigator-initiated studies and external research collaborations. These are conducted in accordance with applicable standards and regulations to produce quality clinical evidence to support the regulatory and marketing strategy for Pathology JV products. 
 
You will have the opportunity to manage clinical studies involving cross-functional internal and external stakeholders to evaluate SAMD AI products. You will be responsible for contributing to, managing and delivering a range of essential documents and processes supporting the development of Pathology JV products. This is an excellent opportunity to conduct clinical studies, support regulatory approval and business strategy and publish research within the growing field of applied AI in healthcare.  
 
You are motivated, efficient and have a proven track record of meeting project timelines and delivering results. Your accountabilities will be spread across study management, clinical evaluation activities, SOP development and the delivery of protocols, ethics approvals, study reports, and manuscripts. Your strong written and verbal communication skills will see you successfully coordinate complex discussions and decisions between a wide range of internal and external stakeholders.   
 
As we pioneer new ways of improving healthcare delivery at scale using cutting edge AI technologies, we invite you to consider an exciting, meaningful career with us here  in the Clinical Research Team. 

What you'll do

  • Plan, execute and ongoing risk management for assigned clinical studies   
  • Contribute to and managing timely completion (with cross-functional input) of documentation and activities supporting the development of Pathology JV products including:  
  • Clinical Study Proposals and Plans  
  • Ethics submissions  
  • Clinical Study Protocols, Statistical Analysis Plans and Clinical Study Reports  
  • Clinical Evaluation Plans and Reports and associated activities including: 
  • Literature Reviews, including generation of Literature Review Plans and Reports  
  • Post Market Surveillance and Post Market Clinical Follow Up Plans and Reports  
  • Conduct or assist with manuscript submissions and conference abstracts as required  
  • Effectively manage external and internal stakeholders (e.g. lead clinicians, regulatory, quality, product, technical, and systems).  
  • Assist with SOP development supporting the Clinical Research team  
  • What we're looking for

  • Experience working within the field of clinical research; 
  • Experience in the medical device industry; 
  • A Bachelor’s or Master’s degree in a relevant field (e.g., nursing, life sciences or medical science); and 
  • Strong knowledge and understanding of ICH GCP requirements. 
  • Nice to haves

  • PhD and/or post-graduate qualification in a relevant area of medical science; 
  • Management consulting experience; 
  • Experience working in research involving artificial intelligence, SAMD and/or pathology; 
  • A proven ability to publish in high impact peer-reviewed journals; 
  • Experience working with regulatory bodies, including an understanding of regulatory requirements in relation to clinical studies (FDA, TGA, EU); and 
  • An understanding of reimbursement and health economic analysis. 
  • What’s next?

    Thank you for considering becoming part of the team. Please apply now to register your interest and we look forward to reviewing your application shortly.

    We are deeply committed to Equal Employment Opportunities and we strongly support an inclusive work environment. We believe that bringing diverse individuals together enables us to build a better product and company. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage in the application or interview process, please let us know.