The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.
Key Responsibilities
* Identify, assess, and initiate investigational sites
* Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
* Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
* Perform source data verification and ensure data accuracy and completeness
* Monitor patient recruitment and support sites in meeting targets
* Ensure proper reporting of adverse events and protocol deviations
* Manage investigational product handling, storage, and accountability
* Maintain study documentation (TMF/eTMF, Investigator Files)
* Write monitoring reports and follow-up communications
* Collaborate with project teams, sponsors, and site staff
* Support audits/inspections and mentor junior CRAs
Requirements
* Degree in a scientific field
* Minimum 2 years' CRA or clinical trial monitoring experience
* Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
* Good English and Microsoft Office skills
* Strong organizational, communication, and problem-solving abilities
* Ability to work independently and in a team
What we offer
We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.
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