Clinical Research Associate
Zydus Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Pennington • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $100,000 - $110,000 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- 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
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
- 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
Benefits
- Equal employment opportunities
- Prohibits discrimination and harassment
- Reasonable accommodation for individuals with disabilities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site monitoringsite qualification visitssite initiation visitsperiodic monitoring visitsclose-out visitssafety monitoringprotocol compliancerecruitment planninginvestigational site file managementnoncompliance prevention
Soft skills
organizational skillseffective communicationindependent workpresentation skills