[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.ResponsibilitiesOversee data review, query resolution, and Source Data Verification (SDV) in EDC systemsSupport site management activities including site initiation, monitoring, and close-out (remote and onsite)Ensure compliance with study protocols, ICH-GCP, FDA, and global regulatory requirementsMaintain and audit eTMF, ISF, and essential regulatory documentsMonitor subject recruitment, data entry timelines, and protocol deviationsManage investigational product (IP) tracking and accountabilityTrain site staff on protocol and GCP complianceAssist with development of CRFs, informed consent forms, and monitoring plansContribute to CAPA development, audit readiness, and inspection supportCollaborate cross-functionally to meet trial milestonesUtilize EDC, CTMS, and other clinical trial systems efficientlySkillsWorked for a sponsor, preferably IVD or Device but would consider drug developmentAbility to take initiative, tech savvyBachelor's in Life Sciences or related field4+ years in clinical research; IVD and site monitoring experience requiredExpertise in EDC, CTMS, eTMF, and regulatory complianceStrong problem-solving, communication, and organizational skillsPreference for East coast or CentralCompany OverviewClinovo provides drug development and solutions. It was founded in 2003, and is headquartered in Kendall Park, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://www.clinovo.com/.Company H1B SponsorshipClinovo has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024, 2 in 2023, 1 in 2022. Please note that this does not guarantee sponsorship for this specific role.