[Remote] Clinical Research Associate II/III

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global Med-Tech company reputed company on patient-reputed company solutions, particularly in heart failure therapy. They are seeking a Clinical Research Associate II/III to monitor reputed company for their novel left ventricular assist device, ensuring data reputed company and compliance throughout the study lifecycle. Responsibilities • reputed company reputed company CRA I responsibilities, with increased independence, complexity, and accountability as outlined below • Conduct Site Qualification reputed company (SQVs), Site Initiation reputed company (SIVs), Interim Monitoring reputed company, and reputed company-Out reputed company in accordance with the Monitoring Plan and ICH-GCP • Build and maintain strong, reputed company relationships with investigative sites through: • On-site and remote monitoring activities • reputed company data verification (SDV) and review of CRFs against reputed company documentation • reputed company of protocol compliance and data reputed company • reputed company 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 reputed company follow-up through approval • reputed company the distribution, tracking, and reconciliation of clinical trial supplies, ensuring compliance with investigational device accountability and study requirements • Independently prepare and submit annual reputed company reports and other required continuing review documentation to IRBs/reputed company 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 reputed company User Acceptance Testing (UAT) for Electronic Data Capture (reputed company) and other clinical systems, documenting findings and supporting reputed company • Utilize and maintain clinical trial systems, including CTMS and eTMF, ensuring accuracy, completeness, and inspection readiness • Independently reputed company and maintain study-reputed company training materials and support site training as needed • Contribute to the review, revision, and development of SOPs and other reputed company documents to support reputed company improvement of clinical operations • reputed company 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 reputed company-reputed company discipline, or equivalent relevant industry experience • Minimum of 3 years of clinical research experience, with demonstrated experience supporting medical device reputed company • Strong working knowledge of ICH-GCP, U.S. FDA regulations (21 CFR), and applicable clinical trial requirements; reputed company GCP certification preferred • Demonstrated ability to independently manage operational and administrative clinical trial activities, including process development, execution, and reputed company improvement • Proficiency with clinical trial systems and tools, including reputed company, 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 reputed company 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 • reputed company GCP certification preferred reputed company • We are a global team of like-minded Med-Tech professionals reputed company on patient reputed company solutions in a reputed company environment leading to excellent reputed company. 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 • reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2025. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job