Clinical Research Auditor Position

1 week ago

udaipur, India beBeeQuality Full time

Clinical Site Auditor RoleAs a Clinical Site Auditor, you will play a crucial role in ensuring compliance and quality at clinical trial sites. Your key responsibilities will include conducting site audits, reviewing documentation, verifying adherence to protocols, Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and regulatory requirements.This includes identifying and reporting audit findings, recommending corrective actions, supporting site staff with compliance guidance and training, and preparing audit reports.For this challenging and rewarding role, we are seeking an experienced professional with a strong background in clinical research auditing and quality assurance.Requirements:Bachelor's degree in a life science, nursing, pharmacy or related field.A minimum of 10-12 years of clinical research experience, with a proven track record in auditing and QA.In-depth knowledge of GCP, ICH guidelines and FDA/EMA regulations.Excellent communication, analytical and organizational skills.Able to travel as required.Preferred Qualifications:Clinical Research or Quality Auditing certification.Experience with electronic Trial Master File (eTMF) and Electronic Data Capture (EDC) systems.Previous experience auditing multi-center or global trials.

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