Clinical Site Quality Assurance Specialist
2 weeks ago
Clinical Site Quality Assurance SpecialistClinical site quality assurance specialists play a crucial role in ensuring compliance and quality at clinical trial sites. Their primary responsibility is to conduct site audits, review documentation, and verify adherence to protocols, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and regulatory requirements.This position requires strong analytical and organizational skills to effectively manage multiple audits and projects simultaneously. The ability to communicate complex information to site staff and other stakeholders is also essential.A bachelor's degree in life sciences, nursing, pharmacy, or a related field is required. Additionally, 10-12 years of clinical research experience, with auditing and quality assurance experience, is necessary for success in this role.The ideal candidate will have knowledge of GCP, ICH guidelines, and FDA/EMA regulations. Experience with electronic Trial Master File (eTMF) and Electronic Data Capture (EDC) systems is also beneficial.Responsibilities:Conduct site audits to ensure compliance with protocols, GCP, GLP, and regulatory requirementsReview documentation, including Case Report Forms (CRFs), informed consent forms, and regulatory documentsIdentify and report audit findings; recommend corrective actionsProvide training and guidance to site staff on compliance and quality standardsPrepare audit reports and follow up on Corrective Action Preventive Action (CAPA) implementationRequirements:Bachelor's degree in life sciences, nursing, pharmacy, or related field10-12 years of clinical research experience, with auditing and QA experienceKnowledge of GCP, ICH guidelines, and FDA/EMA regulationsStrong communication, analytical, and organizational skillsAbility to travel is requiredPreferred Skills:Clinical Research or Quality Auditing certification (ACRP, SOCRA)Experience with eTMF and EDC systemsExperience auditing multi-center or global trialsWorking Conditions:Up to 50% travel to clinical sitesCombination of remote and field workFlexible schedule to accommodate site audits
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Warehouse Quality Assurance Specialist
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Data Annotation and Quality Assurance Specialist
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Clinical Research Specialist
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bharatpur, India beBeeQuality Full timeClinical Site Auditors are responsible for ensuring compliance and quality at Clinical Trial sites. Their role involves conducting site audits, reviewing documentation, and verifying adherence to protocols GCP GLP and regulatory requirements.Conducting audits of clinical research sites across phases I–IVReviewing CRFs informed consent forms and regulatory...
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Software Quality Assurance Specialist
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Quality Assurance Specialist
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Software Quality Assurance Position
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AI-Powered Quality Assurance Specialist
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Senior Quality Assurance Specialist
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Software Assurance Specialist
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Quality Assurance and Control Specialist
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