[Remote] Clinical Research Associate II/III

Note: The job is a remote job and is open to candidates in USA. BrioHealth Solutions is expanding its Clinical team and seeking a Clinical Research Associate (CRA II/III) to support the execution of clinical trials for their novel LVAS device. This role is responsible for monitoring trial conduct, ensuring data integrity, and supporting compliance across sites throughout the clinical 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 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 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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