[Remote] Senior Clinical Research Associate - IVD

Note: The job is a remote job and is open to candidates in USA. Clinovo is seeking a Senior Clinical Research Associate for a 3-4 year study that is currently in the startup phase with 3 of 30 sites activated. The role involves overseeing data review, ensuring compliance with regulatory requirements, and managing site activities, with a significant amount of travel expected.

Responsibilities

• Oversee data review, query resolution, and Source Data Verification (SDV) in EDC systems
• Support site management activities including site initiation, monitoring, and close-out (remote and onsite)
• Ensure compliance with study protocols, ICH-GCP, FDA, and global regulatory requirements
• Maintain and audit eTMF, ISF, and essential regulatory documents
• Monitor subject recruitment, data entry timelines, and protocol deviations
• Manage investigational product (IP) tracking and accountability
• Train site staff on protocol and GCP compliance
• Assist with development of CRFs, informed consent forms, and monitoring plans
• Contribute to CAPA development, audit readiness, and inspection support
• Collaborate cross-functionally to meet trial milestones
• Utilize EDC, CTMS, and other clinical trial systems efficiently

Skills

• Worked for a sponsor, preferably IVD or Device but would consider drug development
• Ability to take initiative, tech savvy
• Bachelor's in Life Sciences or related field
• 4+ years in clinical research; IVD and site monitoring experience required
• Expertise in EDC, CTMS, eTMF, and regulatory compliance
• Strong problem-solving, communication, and organizational skills
• Preference for East coast or Central

Company Overview

Company H1B Sponsorship