Clinical Site Compliance Specialist

2 weeks ago

solapur, India beBeeAuditor Full time

Job Title: Clinical Site AuditorClinical Site Auditors ensure compliance and quality at clinical trial sites. They conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP, and regulatory requirements.Key Responsibilities:Conducting audits of clinical research sites across phases I–IV.Reviewing CRFs, informed consent forms, and regulatory documents.Identifying and reporting audit findings; recommending corrective actions.Providing compliance guidance and training to site staff.Preparing audit reports and following up on CAPA implementation.Qualifications:Bachelor's degree in life sciences, nursing, pharmacy, or a related field.A minimum of 10-12 years of clinical research experience, with auditing and QA experience.Knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Strong communication, analytical, and organizational skills.Ability to travel is required.Preferred Qualifications:Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience with eTMF and EDC systems.Experience auditing multi-center or global trials.Working Conditions:Up to 50% travel to clinical sites.A combination of remote and field work.Flexible schedule to accommodate site audits.

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