Clinical Compliance Specialist

3 days ago

Gandhinagar, India beBeeClinical Full time

We are seeking a seasoned Clinical Quality Compliance Specialist to join our team.Job Title: Clinical Quality Compliance ManagerThe position entails ensuring compliance and quality at clinical trial sites through conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Main Responsibilities:Audit Conducting: Conduct thorough audits of clinical research sites across phases I–IV.Documentation Review: Review CRFs, informed consent forms, and regulatory documents in detail.Findings Identification: Identify and report audit findings, recommending corrective actions as needed.Compliance Guidance: Provide site staff with guidance on compliance matters and conduct training sessions.Report Preparation: Prepare comprehensive audit reports and ensure follow-up on CAPA implementation.Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or a related field.At least 10 years of experience in clinical research, with a focus on auditing and QA.Familiarity with GCP, ICH guidelines, and FDA/EMA regulations.Strong analytical, communication, and organizational skills.Ability to travel is required for this position.

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