Bharti Kachela

Senior CRA with a proven track record in managing clinical trials, ensuring compliance, and maintaining high-quality standards. Proficient in site monitoring, data collection, and regulatory compliance. Certified in Neuroscience and Neuroimaging, Experienced medical writer in National and international journals e.g. research papers, articles, blogs, concept papers writing, thesis writing and health policy briefs. Having more than 13 publications in International journals including discovery, Taylor Francisco journals etc. with a strong background in translating complex scientific information into clear, engaging content. Proficient in writing clinical trial protocols, regulatory documents, and patient education materials. Experience of Clinical pharmacy and hospital pharmacy in oncology, GI, Nephrology and Infectious diseases with a Proficiency in medication management, patient counseling, and regulatory compliance, Skilled public health researcher with expertise in quantitative and qualitative research methods. Proficient in data analysis, program evaluation, and project management.

• English Fluent Fluent Fluent
• Urdu Fluent Fluent Fluent
• Sindhi Basic Basic Basic

• 2019: Thesis: Living with chronically mentally ill patients; caregiving experiences of primary caregivers. (Qualitative Research via Photovoice method)
• 2016: Successfully Completed Dysmenorrhea research at AEIRC. (Qualitative method)
• 2015: Thesis: Growing public cognizance or perception regarding cervical cancer.(Qualitative and Quantitative Research)
• 2019: Cost evaluation and Analysis project at Aga Khan University.
• Article about, "what does it mean to be healthy"?
• Article about "5 ways to be a more empathetic friend".
• Reflexivity upon Reality, Perception, Paradigm and Paradigm shift.
• Cocept Paper about Genome and Epigenome
• Policy and Health System research related papers

• 2019: Spotlight Award by IQVIA for CLOVER Study
• 2021: Ovation award by IQVIA for Ulcerative Colitis study
• 2024: Ovation award by IQVIA for FSP-Roche Model
• 2024: Bronze Award by Swiz ALVOTECH
• 
  

• Neuroscience and Neuroimaging
• GCP
• GDP
• iMedidata-Data Monitoring tool
• CCRP
• Inform-Data Monitoring tool

• Sponsor: Abbott Laboratories
• Study Phase: Phase 3
  Indication: COVID-19
  Special Population: Elderly
  Drug Class: Vaccines - Antiviral
• # of Patients:218
  Role: Clinical Research Associate I
  Key Responsibilities: Performed site initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice, wrote all monitoring reports and Follow up letter to keep up good documentation practice.
  
• Sponsor: Eiger BioPharmaceuticals, Inc
• Study Phase: Phase 3
  Indication: Viral hepatitis D
  Special Population: Elderly
  Drug Class: Small Molecule (Kinase Inhibitor)
  # of Countries: 21
  # of Sites: 127
  Role: Clinical Research Associate
  Key Responsibilities: Responsible for Co-monitoring at site in Pakistan and for close-out visits as well, in accordance with contracted scope of work and good clinical practice. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Sponsor: Suzhou Connect Biopharmaceuticals, Ltd
• Study Phase: Phase 2
  Indication: Ulcerative Colitis
  Special Population: Elderly
  Drug Class: Gastrointestinal Agents
  # of Countries: 5
  # of Sites: 148
  Role: Clinical Research Associate
  Key Responsibilities:
  Performed site selection, initiation, monitoring in accordance with contracted scope of work and good clinical practice. Also I was accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Sponsor: jiangsu pacific meinuoke biopharmaceutical co., ltd
• Study Phase: Phase 2
  Indication: COVID-19
  Special Population: Elderly
  Drug Class: Biologic (Antibody)
  # of Countries: 4
  # of Sites: 23
  Role: Clinical Research Associate
  Key Responsibilities: Responsible for pharmacy visits as an Unblinded CRA, to maintain the IP accountability and documentation in accordance with contracted scope of work and good clinical practice.
• Sponsor: Clover Biopharmaceuticals AUS Pty Ltd
• Study Phase: Phase 3
  Indication: COVID-19
  Special Population: Elderly
  Drug Class: Vaccines - Antiviral
  # of Countries: 1
  # of Sites: 1
  Role: Clinical Research Associate I
  Key Responsibilities: Remote Monitoring of site in Phillipines
  
• Sponsor: GAVI
• Study Phase: IV
  Indication: Typhoid Fever
  Special Population: Minors
  Drug Class: Vaccines - Antibacterial
  # of Countries: 1
  Role: Clinical Research Associate I
  Key Responsibilities: Responsible for Monitoring of documentation and data.
  
• Sponsor: Shionogi
• Study Phase: Phase 3
  Indication: COVID-19
  Role: Clinical Research Associate II
  Key Responsibilities: Performed SSV for AKUH and Indus hospital in Karachi, Pakistan
• Sponsor: ALVOTEC
• Study Phase: Phase 3
  Indication: Macular Degeneration
  Role: Sr. CRA
• Key Responsibilities:
  Site Monitoring, Documents management, site and study team communication, Site staff training
  
• Sponsor: Hoffmann-La Roche
• Study Phase: Phase 3
  Indication: Non-Small Cell Lung Cancer and Hepatic Carcinoma (Cohort 5 and 6)
  Role: Sr. CRA
  Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training, along with RSU related work
• Sponsor: Seqirus UK
• Study Phase: Phase 3
  Indication: Influenza
  Role: Sr. CRA
  Key Responsibilities: Site Management, Documents management, site and study team communication, Site staff training
• Sponsor: Frontier and Everest
• Study Phase: Phase 3
  Indication: COVID 19
  Role: CRA 2
  Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training
• Sponsor: Prestige Biopharma
• Study Phase: Phase 3
  Indication: Malignant Tumor of Lungs
  Role: CRA 2
  Key Responsibilities: worked as a CTA for this study site located in Malaysia
• Sponsor: NATIONAL CANCER CENTRE OF SINGAPORE [SG]
• Study Phase: Phase 2
  Indication: Malignant Tumor of Lungs
  Role: CRA 2
  Key Responsibilities: worked as a CTA for this study site located in Malaysia
• Sponsor: GSK
• Study Phase: Phase 3
  Indication: Arthritis
  Role: CRA 2
  Key Responsibilities: worked as a CTA for this study site located in Malaysia

• Lean Practitioner
• Participated in patient Centricity Program at IQVIA
• SPSS certified
• Anova Certified