Remote CRA: Site Monitoring & Compliance Lead

Zydus Therapeutics Inc.; Fully; Remote; CHF 82,000 - 90,000; Full time

Job summary

Zydus Therapeutics Inc. is seeking a remote site monitoring professional to oversee ICH/GCP-compliant monitoring activities for multiple sites, including SQVs, SIVs, PMVs, and COVs, in support of our clinical programs.

The role requires strong clinical oversight, data interpretation, and training of site staff, with 70–80% travel. Collaboration with cross-functional teams across pharmacovigilance, data management, and study coordinators to ensure protocol adherence and patient safety is

Qualifications

• Experience in site monitoring activities per ICH/GCP.
• Knowledge of GDP and ALCOA principles.
• Ability to conduct site training and ensure protocol compliance.
• Strong communication and organizational skills.
• Ability to work independently with minimal oversight.
• Experience presenting to stakeholders and site staff.
• Experience overseeing sponsor monitoring activities and complex issue resolution.

Responsibilities

• Responsible for all aspects of site monitoring activities per ICH/GCP.
• Act as primary contact/manager for sites and provide protocol-related guidance.
• Train site staff on protocol materials and safety reporting.
• Ensure safety monitoring and oversight of patient safety aligned with regulatory standards.
• Oversee site recruitment, enrollment, and documentation quality.
• Review Investigational Site File Binder and maintain plans/logs per ICH GCP/GDP.
• Support cross-functional groups with safety data reporting and protocol compliance.
• Provide guidance to prevent noncompliance and escalate issues.

Skills

ICH GCP principles

GDP knowledge

organization skills

communication skills

independent work

presentation skills

oversight of sponsor monitoring

data interpretation

conflict resolution

Tools

Microsoft Outlook

Excel

Word

PowerPoint

CTMS

EDC

eTMF

IWRS

Job description

Zydus Therapeutics Inc. is seeking a remote site monitoring professional to oversee ICH/GCP-compliant monitoring activities for multiple sites, including SQVs, SIVs, PMVs, and COVs, in support of our clinical programs.

The role requires strong clinical oversight, data interpretation, and training of site staff, with 70–80% travel. Collaboration with cross-functional teams across pharmacovigilance, data management, and study coordinators to ensure protocol adherence and patient safety is