Job Description

Position Summary:

We are seeking a motivated Clinical Research Associate to support clinical trial operations through comprehensive on-site and remote monitoring. This individual will play a crucial role in ensuring regulatory compliance, data accuracy, and site engagement throughout the study lifecycle.

Core Responsibilities:

• Conduct monitoring visits—including site qualification, initiation, routine monitoring, and close-out—to ensure clinical trial conduct aligns with protocol requirements and regulatory standards.
• Monitor site performance to verify patient safety, protocol adherence, data quality, and regulatory documentation.
• Assist in identifying and evaluating potential sites across therapeutic areas.
• Educate and support site personnel on study procedures and ensure essential documentation is properly maintained.
• Review subject data and source documentation for accuracy, completeness, and timely entry into electronic case report forms (eCRFs).
• Validate that informed consent is properly documented and that investigational product is stored and administered according to guidelines.
• Ensure timely resolution of data queries and that adverse events, including SAEs, are reported in compliance with study and regulatory expectations.
• Support audit readiness and address any quality assurance observations in a timely manner.

What Success Looks Like:

• Consistently meeting timelines and quality metrics for monitoring deliverables.
• Clear, thorough reporting and follow-up after site visits.
• Positive and proactive engagement with site staff and internal teams.

Key Relationships:

• Reports functionally and administratively to the Clinical Operations Manager.
• Collaborates with other CRAs, clinical team members, site coordinators, and operational support teams.

Qualifications:

• Degree in Life Sciences, Pharmacy, Nursing, or a related field.
• 1–4 years of experience in clinical site monitoring.
• Strong command of clinical trial guidelines, including ICH-GCP.
• Excellent organizational, communication, and time-management skills.
• Capable of managing multiple priorities in a dynamic and deadline-driven environment.

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