Afra Labbay

Clinical Research Coordinator with 1 year of hands-on experience in site-level clinical trial operations.

experience in investigational product accountability, patient coordination, EDC and RTSM systems, maintained TMF, PSF, source document, CRF completion and handled monitoring visits and assisted in USFDA inspection. Coordinated efficiently between PI, CRA, Co-Investigators, and Ethics Committee to facilitate smooth conduct of clinical trials and regulatory compliance. Strong understanding of GCP, protocol compliance, and regulatory requirements.

Clinical Research Coordinator - Adaptive Clinical Research Services (Dr D.Y Patil Hospital & Research Centre Nerul) - Nerul

(2025-06)

• Managed investigational product (IP) receipt, storage, accountability, and documentation.
• Coordinated subject screening, enrollment, visits, and follow-ups per study protocol.
• Supported onsite and remote monitoring visits, resolving queries in collaboration with CRAs.
• Assisted during FDA inspections by preparing source documents and regulatory files.
• Performed accurate data entry and query resolution in EDC systems.
• Handled RTSM activities including subject randomization and documentation.
• Maintain, complete, and compliant source documentation in alignment with GCP standards.

B.SC - Clinical Research, Data Management & Pharmacovigilance - Dr.D.Y. Patil University School Of Medicine (2025-11)

HSC - S.S.High School and Jr. College Nerul, Navi Mumbai (2021)

SSC - CBSE - D.A.V Public School, Nerul, Navi Mumbai (2019)