Clinical Research Site Auditor

2 weeks ago

tumakuru, India beBeeAuditor Full time

Job OverviewClinical site auditors play a pivotal role in ensuring compliance and quality at clinical trial sites.They conduct thorough audits of clinical research sites across various phases, from I to IV.Reviewing case report forms (CRFs), informed consent documents, and regulatory files is an integral part of their duties.Identifying and reporting audit findings, along with recommending corrective actions, are essential tasks for these professionals.Providing guidance and training to site staff on compliance matters is also a key responsibility.Preparing comprehensive audit reports and following up on corrective action implementation is the final step in the process.Qualified candidates will hold a bachelor's degree in life sciences, nursing, pharmacy, or a related field. A minimum of 10-12 years of experience in clinical research, with a focus on auditing and quality assurance, is also required. Familiarity with GCP, ICH guidelines, and FDA/EMA regulations is necessary for success in this role.

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