Clinical Research Associate- West Coast
About The Position
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. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow.
Requirements
- Must display proper knowledge of ICH GCP principles and GDP knowledge for compliance with document review/ reporting; ALCOA principles
- Must be able to demonstrate proper organizational skills and have effective communication skills.
- Must be able to work independently managing sites with minimal oversight
- Must be able to demonstrate ability to conduct presentations as necessary
- Must 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 issues
- Must 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 systems
Responsibilities
- Responsible 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 principles.
- Act 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 materials
- Ensure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirements
- Acts 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 management
- Review sites recruitment and enrollment activities and assist with recruitment planning and solutions as needed.
- Ensure 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 requirements
- Will 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 materials
- Will perform site oversight to prevent noncompliance, escalate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as needed
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
