Job Description

Job Title:Clinical Research Associate 

Employment Status: Full Time, Permanent   

Practice: RAQACA 

Location: Remote, US Based, with domestic and international travel (25-50% depending on the project life cycle).  

Salary: $65,000 - $80,000

Company:  

Do you want to make a difference while advancing your career? Come join Osler. 

We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives. 

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally. 

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research. 

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch. 

Join us and help build a better future. 

About the role  

This role will support the clinical execution and management of all aspects of assigned clinical studies, specifically IVD medical device projects.  

Under the supervision of the Clinical Affairs Lead, the CRA will have responsibility for site management and monitoring activities at assigned sites across assigned programs ensuring the study is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable quality standards - SOPs/Work Instructions.  

Activities may include, but are not limited to, site qualification visits, site initiation, recruiting study participants, creating study documentation, collecting patient data, site monitoring and close-out visits. 

Key Responsibilities:  

Pre-Clinical Testing:

Support Research and Development with identification, qualification, acquisition and monitoring of sites for patient samples and sites for testing to support pre-Clinical Studies: 

• Clinical Samples to be used​. 

• Shipment of instruments and reagents​. 
• Sites that are qualified. 
• Monitoring of documents and sites​. 
• Contracts with Sites. 

SOP/Compliance:​  

• Support the development and maintenance of Clinical SOPs/Work Instructions/Templates. 
• eTMF/eDC vendor and implementation. 
• Site Qualification Visits for EU, UK, and US sites for pre-clinical and clinical programs​. 

Sample Collection – Prospective and Retrospective Samples:​ 

• Management of prospective and retrospective patient samples. 
• Acquisition and compliance of samples​. 
• Contracts with sites​. 
• Monitoring of documents and sites.

Inter-Laboratory-Reproducibility and Clinical Study:​ 

• To perform the CA portion and monitor​. 
• To monitor the CRO being used and data. 

Skills & Experience:  

Essential: 

• Bachelor’s degree, preferably in a medical/scientific field
• Extensive hands-on experience within the medical device (IVD preferred) industry. 
• Comprehensive experience supporting clinical research within the medical device (IVD preferred) industry. 

• In-depth knowledge and proficiency regarding clinical requirements in US (FDA) regulations, EU (IVDR), UK (MHRA) and ICH/GCP guidelines.​ 
• Ability to anticipate and meet deadlines, prioritize work, and the ability to retain confidential information.​ 
• Strong attention to detail.
• Proficiency in MS Office, including PowerPoint, Excel, and Word.​ 
• Must be customer service oriented with strong interpersonal skills.​ 
• Excellent organizational, written, and verbal communication skills.​ 
• Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels.​ 
• Ability to multitask effectively while maintaining high-quality outputs.​ 
• A valid passport for international travel. 

Desirable:  

• Writing SOP/Template experience. 
• Master’s degree, preferably in a medical/scientific field. 
• IVD clinical study experience

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