[Remote] Clinical Research Associate II

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 to support the execution of reputed company for their novel Left Ventricular Assist System (LVAS), responsible for monitoring trial conduct and ensuring data reputed company across clinical sites.

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

Company H1B Sponsorship