Clinical Site Compliance Specialist

2 weeks ago


udaipur, India beBeeAuditor Full time

Clinical Site Audit Role OverviewEnsure compliance and quality at Clinical Trial sites by conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP and regulatory requirements.Conduct on-site audits of clinical research sites across phases I–IV, utilizing expertise in auditing and QA processes.Review CRFs, informed consent forms, and regulatory documents to ensure accuracy and completeness.Identify and report audit findings; provide recommendations for corrective actions to improve site performance.Provide guidance and training to site staff on compliance matters, ensuring seamless execution of trials.Prepare comprehensive audit reports and follow up on CAPA implementation to guarantee continuous improvement.Key Requirements:Bachelor's degree in life sciences, nursing, pharmacy or related field.Minimum 10-12 years of clinical research experience with a proven track record in auditing and QA.Thorough knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Exceptional communication, analytical, and organizational skills to effectively manage multiple priorities.Why This Role Matters:This position plays a critical role in ensuring the integrity and success of clinical trials. As a Clinical Site Auditor, you will be responsible for ensuring that clinical trial sites are operating in accordance with Good Clinical Practices (GCP) and relevant regulations. Your expertise will help to identify and mitigate potential risks, thereby protecting the rights and safety of study participants.What We Offer:This is an excellent opportunity for individuals who are passionate about ensuring the highest standards of quality and compliance in clinical research. Our organization offers a dynamic work environment, opportunities for professional growth, and a competitive compensation package.



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