Souvik Nandi

Experience

1. Clinical Research Coordinator

   Infoclin Consultancy

   Aug 2024 — Present · Kolkata, IN

   Assisted in the planning and coordination of Phase II–IV clinical trials across therapeutic areas including Psychiatry, Respiratory Immunology.•Hands-on experience in multi-phase studies:Phase Stress & Anxiety, Asthma, Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, COPD.Phase IV: Mild to Moderate AsthmaPhase II: Moderate to Severe Asthma• Performed subject pre-screening, eligibility checks, and supported informed consent discussions, ensuring ethical and regulatory compliance.• Coordinated patient visits, obtained proper informed consent, and maintained accurate source documentation in line with study protocols and ICH-GCP guidelines.• Proficient in EDC platforms: iMedidata, Clinion, CodeMDx, Cronos, and CodeAngelo for data entry, query resolution, and data validation.• Experienced with IWRS/CodeITRS systems for subject randomization, drug accountability, and visit tracking, ensuring audit readiness and protocol adherence.• Collaborated with sponsor monitors (CRAs) during site visits, supporting query resolution and essential documentation.• Assisted in pre-study site preparation, feasibility assessments, and TMF maintenance.• Ensured timely reporting of AEs and SAEs, meeting regulatory and sponsor requirements.• Facilitated communication with Ethics Committees (ECs) for submissions, amendments, re-approvals, and compliance queries.

Education

• Aditya Bangalore Institute For Pharmacy Education and Research

  Bachelor of Pharmacy - BPharm