Manognya Sama

About Manognya Sama

I am a motivated and aspiring regulatory affairs professional with a strong pharmacy…

Experience

1. Clinical Research Coordinator

   Apex Medical

   Jan 2024 — Present · Chicago, IL, US

   Worked as clinical study coordinator in Knee study sponsored by Organogenesis and also helped out in other studies like cholesterol study.• Did day to day study conduct tasks like patient recruitment, scheduling participants, randomization, screening visits, follow-up visits with each subject screened and enrolled in the study.• Consenting patients and discussing about drug, study purpose, procedures, duration, ADEs, risks and benefits of participation etc.• Solved queries in imedidata (Rave EDC).• Coordinated with study sponsors, principal investigator, sub-investigator and study team members, collected adverse events, and reported to sponsor.• Maintained accurate and organized study records, including case report forms (CRFs) and source documents in EDC and subject binders.• Did blood draws for patients, ECG, X-Rays of knee. Also processed labs and packaged and shipped to ACM laboratories as per GLP and SOPs.• Ordered study supplies from sponsor, refilled all study supplies in lab and disposed bioharzard wastes in accordance with protocol and regulatory guidelines.

Education

• Sri Chaithanya junior college

  Intermediate

  2012 — 2014

• Northeastern University

  Masters of science in Regulatory affairs in drugs and biologics

• Chillukur Balaji College of Pharmacy

  Doctor of Pharmacy - PharmD

  2015 — 2021