Quality Control Officer - Clinical Research

Responsibilities

• Understanding the study requirements, ethical guidelines (ICH GCP, ICMR, and Indian GCP), SOPs, and regulatory requirements (NDCT Rules 2019) to develop effective quality control processes
• Conduct/Facilitate the applicable trainings/training program
• Ensure the study member undergoes applicable study-related training as per role and responsibilities
• Establish and implement quality control processes
• Prepare/Review the study templates/study documents, including source documents, logs/forms, and study-specific SOPs/Manual of procedures
• Quality control of study documents and procedures/processes and ensure compliance with study protocol, SOPs, and applicable ethical and regulatory requirements
• Preparatory activities for the site monitoring visit and assist CRAs in routine monitoring visits by resolving queries, clarifying data, follow-up, and action items.
• Conduct internal review or audit of the ongoing study and implement the CAPA
• Coordinate and prepare the site for audit, inspections, EC monitoring, and site evaluation visits, if any
• Review and coordinate the Ethics committee submissions, notifications, approvals, deviations, if any, and other significant communications

Qualifications

• Bachelor or Master degree in life science/pharmacy/health science
• 2-3 years of relevant experience in clinical research
• Strong analytical, written and verbal skills
• Ability to work in critical timelimes and multitasking

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