[Remote] Clinical Research Associate II/III

Note: The job is a remote job and is open to candidates in USA. BrioHealth Solutions is a global Med-Tech company focused on patient-centric solutions, particularly in heart failure therapy. They are seeking a Clinical Research Associate II/III to monitor clinical trials for their novel left ventricular assist device, ensuring data integrity and compliance throughout the study lifecycle.

Responsibilities

• Perform all CRA I responsibilities, with increased independence, complexity, and accountability as outlined below
• Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits, and Close-Out Visits in accordance with the Monitoring Plan and ICH-GCP
• Build and maintain strong, professional relationships with investigative sites through:
• On-site and remote monitoring activities
• Source data verification (SDV) and review of CRFs against source documentation
• Oversight of protocol compliance and data quality
• Timely and accurate preparation of monitoring visit reports
• Management and reconciliation of investigational device accountability
• Independently manage site-level regulatory submissions, including IRB/EC and applicable regulatory authority submissions, ensuring completeness, accuracy, and timely follow-up through approval
• Oversee the distribution, tracking, and reconciliation of clinical trial supplies, ensuring compliance with investigational device accountability and study requirements
• Independently prepare and submit annual progress reports and other required continuing review documentation to IRBs/ECs and Regulatory Authorities
• Support investigative sites with the identification, documentation, and reporting of Serious Adverse Events (SAEs) in accordance with protocol, SOPs, and regulatory requirements
• Independently perform User Acceptance Testing (UAT) for Electronic Data Capture (EDC) and other clinical systems, documenting findings and supporting resolution
• Utilize and maintain clinical trial systems, including CTMS and eTMF, ensuring accuracy, completeness, and inspection readiness
• Independently develop and maintain study-related training materials and support site training as needed
• Contribute to the review, revision, and development of SOPs and other quality documents to support continuous improvement of clinical operations
• Provide on-the-job training, mentorship, and guidance to CRA I team members; support co-monitoring activities and escalation as requested by CRA III or Clinical leadership

Skills

• Bachelor's degree or higher in a scientific or healthcare-related discipline, or equivalent relevant industry experience
• Minimum of 3 years of clinical research experience, with demonstrated experience supporting medical device clinical trials
• Strong working knowledge of ICH-GCP, U.S. FDA regulations (21 CFR), and applicable clinical trial requirements; current GCP certification preferred
• Demonstrated ability to independently manage operational and administrative clinical trial activities, including process development, execution, and continuous improvement
• Proficiency with clinical trial systems and tools, including EDC, CTMS, and eTMF platforms
• Solid understanding of clinical trial design principles, data collection methodologies, and basic statistical concepts relevant to clinical research
• Ability to interpret and apply medical and scientific information, including both foundational and complex clinical concepts
• Strong organizational, documentation, and communication skills, with the ability to manage multiple priorities in a regulated environment
• Willingness and ability to travel greater than 30%, as required by study and site needs
• Current GCP certification preferred

Company Overview

• We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. It was founded in 2008, and is headquartered in Suzhou, Jiangsu, CHN, with a workforce of 51-200 employees. Its website is http://www.briohealthtech.com.

Company H1B Sponsorship

• BrioHealth Solutions has a track record of offering H1B sponsorships, with 1 in 2025. Please note that this does not guarantee sponsorship for this specific role.

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