Clinical Data coordinator
Send a job offer directly to this candidate
I am Dr.
Bose, a Pharm D graduate. After my graduation, Istarted working as an assistant clinical data coordinator and clinical Data coordinator at ICON Clinical Research, Trivandrum India in Apr 2019- Nov 2021. I have enough knowledge about the Microsoft tools like Excel, Word, and PowerPoint.
Research subject from my Pharm D program provided me with immense knowledge about clinical research and the various healthcare professionals working on clinical Trials. My eagerness to work in clinical research led me to find a job in data management. I have enjoyed my profession and I am very pleased to continue my career in Clinical Research.
Due to relocation and some family matters I have taken a 1-year career break and now I am very actively looking for a job in the clinical trial. My previous experience in protocol review, CRF guidelines, ICH-GCP guidelines, query writing, query resolution, listing review, all kind of vendor reconciliations, start-up, and close-out activities, UAT, and PPC activities will support my work as a good Clinical Trail Assistant. While working I have communicated with the Project manager, Clinical project manager, CRA, CTA, Medical Coders, Programmers, CDL, and sponsor to ensure a clean database.
I have given training to site coordinators for a proper understanding of DM concepts mentored new team members and performed peer reviews.
Expertly reviewed case report form and data for completeness, compliance, accuracy, and consistency with all applicable procedures. Communicated/coordinated with Project manager, Clinical project manager, CDL, and sponsor to ensure a clean database. Performed listing reviews, external vendor system eCOA Reconciliation, Lab Reconciliations, IVRS Reconciliation, PK Reconciliation, PGx Reconciliation, and SAE Reconciliation. Successfully trained site coordinators for proper understanding of DM concepts mentored new team members and performed peer review. Evaluated and revised SOP’s-Data handling conventions, Manual review, and listing review to reflect current discrepancy management. Practices updated and authored CRF completionguidelines. Initiated quality reviews, Identified all issues, and proposed resolutions. Performed Data Access Training and User Access Training (UAT) to ensure the accuracy of thedatabase. Participated in close-out activities and database finalization.
Accurately review the Case Report Form for completeness, accuracy, and consistency in accordance with all applicable procedures. Performed Quality Reviews and appropriately identified all issues. Performed DM review, Entry Freeze, and Hard lock. Handling external vendor system _Lab Reconciliation.
Doctor of Pharmacy (Pharm D) Swamy Vivekananda College of Pharmacy Tamil Nadu Dr. M.G.R. Medical University Oct 2012- Dec 2018
