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Job summary
A leading clinical trial organization is seeking a Regulatory Coordinator to ensure compliance in clinical trials. This entry-level role involves preparing and maintaining regulatory documents, coordinating with the IRB, and ensuring adherence to relevant regulations. Candidates should possess strong organizational and communication skills and familiarity with FDA guidelines. The position is full-time, located in Chandler, Arizona, offering growth opportunities in the clinical research field.
Qualifications
Prior experience performing regulatory duties preferred but not mandatory.
Strong understanding of FDA regulations, ICH-GCP guidelines, and IRB processes.
Excellent organizational and communication skills with strong attention to detail.
Responsibilities
Prepare, submit, and maintain regulatory documents for clinical trials.
Coordinate initial and continuing review submissions to the IRB.
Maintain regulatory binders and trial master files.
Skills
Organizational skills
Communication skills
Attention to detail
Tools
Microsoft Office Suite
eReg or CTMS
Job description
A leading clinical trial organization is seeking a Regulatory Coordinator to ensure compliance in clinical trials. This entry-level role involves preparing and maintaining regulatory documents, coordinating with the IRB, and ensuring adherence to relevant regulations. Candidates should possess strong organizational and communication skills and familiarity with FDA guidelines. The position is full-time, located in Chandler, Arizona, offering growth opportunities in the clinical research field.