Quality Control Officer - Clinical Research

KEM Hospital Pune; Satara; On-site; INR 600,000 - 900,000; Full time

Job summary

KEM Hospital Pune is seeking a qualified Clinical Research Quality Assurance professional to understand study requirements, guidelines, SOPs, and regulatory rules to build effective control processes. The role involves conducting trainings, ensuring study-related training, and establishing QC processes to ensure protocol and regulatory compliance.

Responsibilities include preparing study documents, leading audits, CAPA implementation, and coordinating site readiness for inspections.

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.

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

Skills

Analytical skills

Written communication

Verbal communication

Multitasking

Education

Bachelor or Master in life science/pharmacy/health science

Job description

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

Disclaimer: This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.