Varanasi, Uttar Pradesh, India
I am a passionate pharmaceutical professional with over +2 years of hands-on experience in coordinating Phase IIa & IIb, III, and IV clinical trials across multiple therapeutic areas. My expertise lies in site coordination, regulatory compliance, subject management, and documentation practices aligned with GCP and ICH guidelines. I bring a proactive attitude, attention to detail, and a deep commitment to quality and ethics in clinical research. I can contribute to high-quality site management and data integrity across multicenteric trials.
• Coordinated with Clinical Trial Supply teams for inventory management, shipment coordination, and compliance. • Managed site selection documentation, feasibility assessments, and Ethics Committee submissions. • Created, reviewed, and conducted Quality Control (QC) on study documents (visit logs, CRFs, site initiation packages, source documents). • Used Excel & Google Spreadsheets for trial data tracking and analysis. • Coordinated with central/local labs for visit-specific lab procedures. • Ensured proper IP accountability at the site.
-Conducted Phase II/III trials ensuring regulatory compliance (CDSCO, USFDA). -Assisted in dossier preparation for regulatory submissions. -Managed SAE reporting & MedDRA coding for safety reporting.(SUGAM Portal) -Ensured adherence to GCP, ICH, and regulatory guidelines. -Monitored Serious Adverse Events (SAE) reporting and ensured submission via Sugam Portal.
1. Investigator & Site Support - Assisted the Principal Investigator (PI) in managing all necessary study documentation. - Maintained investigator site files (ISF), ensuring compliance with ICH-GCP and regulatory guidelines. - Acted as the primary communication link between the investigator and the sponsor. 2. Regulatory & Compliance - Ensured proper documentation of the Informed Consent Process, strictly following protocol & ethical guidelines. - Conducted site monitoring visits, ensuring compliance with regulatory requirements and protocol adherence. - Assisted in site audits & inspections, ensuring regulatory compliance. 3. Study Documentation & Data Management - Managed comprehensive site documentation, including source data, Case Report Forms (CRFs), subject logs, and regulatory binders. - Ensured accurate CRF completion, validating data transcription from source documents. - Performed eCRF data validation & quality checks to ensure consistency and accuracy. - Maintained electronic Trial Master File (eTMF) for proper regulatory document tracking. 4. Subject & Site Coordination - Coordinated with subjects for follow-up visits, ensuring protocol adherence. - Assisted the investigator in subject follow-up appointments and adverse event (AE) documentation. - Conducted pre-study feasibility assessments and site initiation activities. 5. Investigational Product (IP) & Lab Coordination - Ensured Investigational Product (IP) accountability, including storage, dispensing, and reconciliation. - Liaised with central & local laboratories, ensuring timely execution of visit-specific lab procedures. 6. Electronic Data Capture (EDC) & Digital Systems - Managed EDC tasks using Clinvigilant, Cronos, and Octalsoft software systems. - Performed data entry, query resolution, and reconciliation in EDC platforms.
• Managed informed consent documentation and supported investigators in patient recruitment. • Maintained investigator site files (ISF) and source data. • Ensured proper IP accountability and coordinated with local/central labs. • Used EDC (Electronic Data Capture) & IVRS/IWRS systems for clinical data entry.