CRA

About us :

Mediwhale is a pioneering AI healthcare startup focusing on predicting cardiovascular, renal, and metabolic disease (CVRM) risks using retinal biomarkers. The eye is the only organ where blood vessels are directly visible without invasive procedures, which is our key to unlocking unprecedented insights into human health

Our flagship platform solution utilizes ophthalmic-based artificial intelligence to enable personalized cardiovascular disease (CVD) risk prediction. Built on a series of patented machine learning algorithms, our MFDS approved software as a medical device platform provides convenient CVD risk assessment in point-of-care settings.

Responsibilities :

As a CRA, you will be responsible for independently managing all aspects of clinical research in South Korea. This includes overseeing on-site clinical studies, ensuring adherence to timelines, and maintaining high-quality documentation. You will collaborate with local investigators, provide feedback to cross-functional teams, and contribute to product development and regulatory processes. This role requires frequent travel to study sites and reports directly to the Head of Clinical Operations in Singapore. You will also have opportunities for interaction and involvement in global clinical operations.

• Independently generate, write, and edit study protocols, informed consents, case report forms, study reports, monitoring plans, and other clinical and regulatory documents
• Manage pre- and post-market clinical studies from initiation to closure, ensuring compliance with industry standards, best practices, and study protocols. 
• Maintain the trial master file and oversee study-related documentation, including medical images.  
• Prepare for and conduct investigators’ meetings, fostering effective communication and collaboration. 
• Resolve discrepancies and address issues promptly, working closely with site personnel. 
• Directly contribute to study recruitment and informed consent procedures. 

Qualifications :

• PhD, PharmD, RN or equivalent; BA/BS degree with relevant healthcare background may be considered. 
• Minimum 2 years of independent clinical trial management in Korea, preferably in medical devices. 
• Thorough understanding of medical device clinical trial design, MFDS regulations and other applicable industry standards. 
• Proficiency in medical terminology related to cardiology, nephrology, and ophthalmology desired. 
• Strong written and oral communication skills in both English and Korean. 
• Ability to build and maintain effective relationships with trial center colleagues and staff. 
• Excellent time management and prioritization abilities, with a keen attention to detail. 
• Willingness to travel domestically as required. 

Benefits :

• Flexible working conditions including work-from-home (2 days per week).
• Company supported daily lunch and snacks.
• Annual comprehensive health Check-up
• Support for congratulatory or condolence expenses. 
• Medical expense support (covered by group insurance).
• Additional leaves including vaccine leave, birthday leave, and condolence leave, in addition to statutory annual leave. 
• Support for work-related books and job-related training. 

Application Process :

•  Process: Document screening – 1st interview – 2nd interview – Final Acceptance.
  • Tasks may be assigned according to the role, and the interview process may be subject to change
• Application documents: Free format (including resume).
• Interviews: Each interview is expected to take approximately 60 minutes
  • Some interviews may be conducted in English or through video call