Sunil Kumar Nagaraja

Medical Monitor for Clinical trials

• Patient recruitment into trails based on eligibility criteria
• Provided training and support to site personnel on study procedures and protocols.
• Monitored adherence to Good Clinical Practices throughout all phases of a study.
• Reviewed adverse event reports submitted by sites during trials and reported findings back to sponsors or PIs.
• Safety assessment, query to the sites and site query responses

Medical reviewer

• ICSR
• Causality and severity assessment

• Conducted clinical trials to assess drug safety and efficacy.
• Collaborated with cross-functional teams to ensure compliance with regulations.
• Designed study protocols and informed consent documents for participant recruitment.
• Mentored junior staff on best practices in clinical research methodologies.
• Participated in training sessions with investigative sites to ensure proper understanding of GCPs and protocol requirements.
• Reviewed literature related to therapeutic areas under investigation.
• Reviewed protocols and case report forms for accuracy and compliance with regulatory requirements.
• Identified potential risks associated with clinical trials prior to initiation of studies.
• Faced regulatory audits like US FDA, EMEA and DCGI
• Managed laboratory inventory and ensured compliance with safety regulations.

• Provided inputs for protocol development
• Conducted BA-BE studies
• Ensured trial is completed as per GCP and regulatory guidelines
• Participants safety management and documentation in lines with GCP
• Adherent to GDP
• Mentored junior researchers on best practices and methodologies.
• Ensured compliance with ethical standards in all research activities.

• Coordinated data collection and analysis for regulatory submissions.
• Mentored junior researchers on best practices and methodologies.
• Reviewed scientific literature to support ongoing research initiatives.
• Ensured compliance with ethical standards in all research activities.
• Monitored overall progress of projects against timelines and deliverables ensuring timely completion.
• Safety management and documentation