Remote Clinical Research Associate- Midwest region

Note: The job is a remote job and is open to candidates in USA. Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. The Clinical Research Associate will be responsible for all aspects of site monitoring activities and act as the primary contact for assigned sites to ensure compliance with protocols and patient safety.ResponsibilitiesResponsible for of all aspects of site monitoring activities; Including the conduct of Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Periodic Monitoring Visits (PMVs) and Close-out Visits (COVs) in accordance with ICH/GCP principlesAct as the primary contact/ manager for sites to include, but not limited to the following activities:Provide proper training and guidance to site staff on the protocol and all study related materialsEnsure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirementsActs as the primary contact to assigned sites to ensure there is proper compliance to the protocol, adherence to patient safety, proper IP management and study supply managementReview sites recruitment and enrollment activities and assist with recruitment planning and solutions as neededEnsure proper review of the sites Investigational Site File Binder and ensure all plans, communications and logs are maintained and updated appropriately as per ICH GCP and GDP requirementsWill provide support to all functional groups (as needed) to ensure proper reporting of safety data and proper site compliance to all protocol and protocol related materialsWill perform site oversight to prevent noncompliance, escalate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as neededSkillsMust display proper knowledge of ICH GCP principles and GDP knowledge for compliance with document review/ reporting; ALCOA principlesMust be able to demonstrate proper organizational skills and have effective communication skillsMust be able to work independently managing sites with minimal oversightMust be able to demonstrate ability to conduct presentations as necessaryMust be able to assist and have experience with oversight of sponsor monitoring activities. This will include: Data interpretation, conflict resolution and demonstration of working with different personnel, & provide guidance and solutions for complex issuesMust have basic knowledge of system tools and web based applications that include, but not limited to: Microsoft Outlook, Excel, Word and Powerpoint, CTMS, EDC, eTMF and IWRS systemsCompany OverviewZydus Therapeutics develops clinical-stage therapies for conditions like primary biliary cholangitis and nonalcoholic steatohepatitis. It was founded in 2021, and is headquartered in Pennington, New Jersey, USA, with a workforce of 11-50 employees. Its website is https://www.zydustx.com.Company H1B SponsorshipZydus Therapeutics has a track record of offering H1B sponsorships, with 2 in 2026, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role. Apply To this Job .