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I work closely with Senior individuals within the Life Science industry across Europe & the US to scale their businesses.
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.
Seniority level
Employment type
Job function
Job function
ScienceIndustries
Pharmaceutical Manufacturing and Biotechnology Research
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