Remote CRA — Site Monitoring & Safety Oversight

Zydus Therapeutics Inc.; New Jersey; Remote; USD 70,000 - 100,000; Full time

Job summary

Zydus Therapeutics is seeking a Clinical Research Associate for the Midwest region. This fully remote role involves monitoring and managing site activities in compliance with ICH/GCP and GDP.

You will train site staff, ensure safety reporting, and collaborate with sponsor monitoring, data interpretation, and issue resolution. Travel up to 70-80% as needed; occasional visits to the Pennington, NJ office may occur.

Qualifications

• Must follow ICH GCP and GDP compliance with ALCOA principles.
• Demonstrate strong organizational and communication skills.
• Able to work independently with minimal oversight.
• Ability to conduct presentations as needed.
• Experience with sponsor monitoring oversight, data interpretation, and issue resolution.
• Familiarity with common trial systems (CTMS, EDC, eTMF, IWRS).

Responsibilities

• Responsible for all aspects of site monitoring activities including SQVs, SIVs, PMVs and COVs per ICH/GCP.
• Act as primary contact/manager for sites.
• Provide training to site staff on protocol and study materials.
• Ensure safety monitoring reviewed ongoing and site has oversight of safety reporting.
• Acts as primary contact to assigned sites to ensure protocol compliance and patient safety.
• Review site recruitment/enrollment activities and assist with planning.
• Review Investigational Site File Binder and ensure plans/logs are maintained per ICH GCP and GDP.
• Provide support to functional groups to ensure proper reporting of safety data.
• Perform site oversight to prevent noncompliance and guide preventive actions.

Skills

ICH GCP principles

GDP knowledge

Organizational skills

Communication skills

Independent work

Presentation skills

Sponsor monitoring oversight

Tools

Microsoft Outlook

Excel

Word

PowerPoint

CTMS

EDC

eTMF

IWRS

Job description

Zydus Therapeutics is seeking a Clinical Research Associate for the Midwest region. This fully remote role involves monitoring and managing site activities in compliance with ICH/GCP and GDP.

You will train site staff, ensure safety reporting, and collaborate with sponsor monitoring, data interpretation, and issue resolution. Travel up to 70-80% as needed; occasional visits to the Pennington, NJ office may occur.