The Staff CRA supports diagnostic product development by managing clinical trials to ensure regulatory compliance and successful study execution. This role involves oversight of multiple clinical sites and trials, data review, and collaboration with cross-functional teams to drive studies toward approval in the U.S. and internationally.
Qualifications:
- Bachelors degree
- Minimum 3 years previous CRA experience
- IVD/Medical Device experience
Key Responsibilities:
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Manage day-to-day operations of clinical trial sites across several projects.
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Select investigators, develop site relationships, and handle trial documentation.
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Submit protocols to IRBs/Ethics Committees and ensure approvals.
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Monitor trials in compliance with GCP, FDA, and international regulations.
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Oversee logistics for trial materials and clinical sample shipments.
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Track enrollment, ensure timely data entry and query resolution.
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Review and interpret clinical data and prepare reports.
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Maintain complete and organized study documentation.
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Support audits, inspections, and departmental process improvements.
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Mentor junior CRAs and contribute to SOP development.
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