ROHIT KUMAR

Clinical Research Coordination

• Coordinated and supervised the "Sepsis-related mortality in neonates in India" study at VMMC & Safdarjung Hospital, New Delhi (Project managed by AIIMS New Delhi).
• Managed overall study coordination at the site, ensuring adherence to protocols and timelines.
• Supervised and trained research staff, ensuring compliance with Standard Operating Procedures (SOPs) for sepsis monitoring, sample collection, and CRF recording.

Data Management and Quality Control

• Ensured smooth flow of Case Report Forms (CRFs) and supplies, facilitating data entry and verification.
• Independently verified findings of research nurses and accuracy of data entered in CRFs.
• Monitored and reviewed sample collection processes at critical points, such as delivery and suspicion of sepsis, maintaining high standards of data integrity.

Project Management and Coordination

• Coordinated with site Principal Investigators (PIs) for final labelling of culture-positive, culture-negative, and no sepsis cases.
• Supervised study implementation and conducted ongoing Quality Control (QC) activities to ensure study protocols were followed and quality data delivered.
• Managed protocol deviations and addressed issues of loss to follow-up to maintain study integrity.

Collaboration and Communication

• Collaborated effectively with a team of scientists and researchers to design and execute experiments, contributing to the development of new antimicrobial strategies.
• Assisted in organizing and coordinating scientific conferences and seminars, presenting research findings to peers and industry professionals, fostering knowledge exchange and collaboration.

Data Analysis and Reporting

• Conducted thorough data analysis and trend identification, providing insights to support strategic decision-making within the organization.
• Generated timely and accurate reports, offering recommendations to senior management to enable informed decision-making and mitigate risks.

Additional Skills

• Proficient in operating VITEK 2 for microbiological testing and interpreting results.
• Conducts antibiotic susceptibility testing in accordance with CLSI and EUCAST standards, ensuring reliable and accurate results.

API Testing Specialist

• Conducted comprehensive testing of Active Pharmaceutical Ingredients (APIs) to ensure adherence to quality assurance standards and regulatory requirements.
• Implemented testing protocols in accordance with pharmacopeial (IP, USP, EP) standards, ensuring accurate and compliant results.

Medical Devices Cosmetics Testing Expert

• Led quality assessment and testing of Medical devices cosmetics, including skincare, makeup, toiletries, and personal care products.
• Ensured compliance with the Drugs and Cosmetics Act of India and Bureau of Indian Standards (BIS) regulations.

Microbiological Testing and Environmental Monitoring

• Trained in Limulus Amebocyte Lysate (LAL) test for endotoxin testing and bioassay techniques to determine enzyme activity.
• Performed routine microbiological testing on drug products, raw materials, and stability samples using established methodologies and SOPs.
• Conducted environmental monitoring including air and surface sampling, and bacterial endotoxin testing.

HPLC Drug Testing and Instrumentation

• Operated laboratory instruments and conducted High-Performance Liquid Chromatography (HPLC) drug testing using various systems.
• Proficient in data analysis and interpretation to ensure accurate results and compliance with standards.

Molecular Genetics and Water Testing

• Expertise in molecular genetics techniques, including genomic DNA isolation and pulse-field gel electrophoresis.
• Conducted sampling and testing of purified and potable water to ensure compliance with quality standards.

Quality Assurance and Process Improvement

• Developed and executed comprehensive test plans to optimize bench applications and systems, ensuring efficiency and accuracy.
• Collaborated with cross-functional teams to identify and implement process improvements, enhancing operational workflows.

NABL Audit and Compliance

• Participated in NABL audit work, conducting sample analysis and assessing protocols within NABL accreditation scope.
• Ensured adherence to NABL standards and regulatory requirements in testing and laboratory operations.
• Continued professional development in regulatory compliance and laboratory best practices.