Barsha Chakraborty
Islandia
Summary
Clinical research professional with 8+ years of experience coordinating and leading Phase I–IV trials in academic medical centers. Skilled in regulatory submissions, GCP/FDA compliance, EDC platforms, financial oversight and budget development, and sponsor/site collaboration. Proven ability to ensure protocol adherence, drive quality improvement initiatives, and lead cross-functional teams while advancing trial portfolio growth and operational efficiency.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Project Manager
Research Foundation for SUNY, Stony Brook Medicine
Stony Brook
07.2021 - Current
- Coordinate end-to-end clinical trial activities from feasibility and site selection through close-out.
- Develop, maintain, and audit regulatory and source documentation including informed consent forms, SOPs, CRFs, and EMR data.
- Serve as primary liaison for sponsors, CROs, monitors, IRBs, and institutional departments.
- Ensure protocol compliance, GCP/FDA adherence, and timely reporting of adverse events and unanticipated problems.
- Manage EDC queries (InForm, Medidata, REDCap) and collaborate with monitors during remote and onsite visits.
- Oversee financial management of clinical trials including budget development, cost justification, and ongoing reconciliation.
- Support grant submissions, research compliance training, and administrative documentation.
- Conduct QI administrative activities for the Designated AIDS Center, including care cascades, EMR data abstraction, and performance reporting.
- Participate in hiring and interviewing for pediatric research staff, ensuring candidate qualification and onboarding readiness.
- Provide training, mentorship and ongoing guidance to new clinical research staff by assisting with trial procedures and project responsibilities, serving as a support resource and backup coordinator across multiple studies.
Clinical Research Associate
Research Foundation for SUNY, Stony Brook Medicine
Stony Brook
01.2019 - 07.2021
- Maintained protocol compliance and regulatory readiness for multiple clinical research studies.
- Acted as primary contact for sponsor communication, participant coordination, and investigator oversight.
- Prepared and submitted IRB, IACUC, and grant documentation.
- Trained research team members and ensured adherence to GCP standards.
- Created and maintained study materials: source documents, SOPs, CRFs, logs, and consent forms.
Clinical Research Assistant
Research Foundation for SUNY Stony Brook
Stony Brook
09.2017 - 01.2021
- Assisted PIs with clinical trial operations including data entry, sample shipment (IATA), and CRF completion.
- Managed regulatory binders, source documentation, enrollment logs, and consent forms.
- Screened candidates for eligibility and ensured protocol adherence.
Education
Master of Public Health - Health Analytics
Stony Brook Medicine
01.2022
Bachelor of Science - Psychology, Biology
Stony Brook University
01.2017
Skills
- Clinical Trial Operations (Phase I–IV)
- Regulatory Submissions (IRB, IACUC) & Compliance
- Good Clinical Practice (GCP-ICH)
- EDC Systems: InForm, Medidata Rave, REDCap
- Protocol & Site Management
- Participant Screening & Informed Consent
- Budget Development & Financial Management
- Quality Improvement & Data Integrity
- Sponsor/Monitor Liaison & Visit Preparation
- SOP Development & Training
- Adverse Event Reporting
- EMR Documentation & Data Abstraction
- Cross-Functional Team Leadership
- IATA-Compliant Sample Handling
Certification
- ACRP-CP, 2024–2027
- HIPAA Certification
- CITI Certification
- IATA Certification
Credentials
- MPH
- ACRP-CP
Timeline
Clinical Research Project Manager
Research Foundation for SUNY, Stony Brook Medicine
07.2021 - Current
Clinical Research Associate
Research Foundation for SUNY, Stony Brook Medicine
01.2019 - 07.2021
Clinical Research Assistant
Research Foundation for SUNY Stony Brook
09.2017 - 01.2021
Master of Public Health - Health Analytics
Stony Brook Medicine
Bachelor of Science - Psychology, Biology
Stony Brook University