Soujanya
About Me
With nearly a year of experience as a Data coordinator in the field of Clinical Research I have good command in Query Resolution, Data Entry and excellent communication skills. I have a good command of MS office Applications (PowerPoint, Excel etc) and have experience working with EDC system Medidata Rave and REDCap. I create, maintain, and update Trackers as necessary for the study and communicate with other staff as necessary to maintain smooth data flow. I have experience with QC review of EPIC documents.
I have an eye to detail in relation to QC review of documents making sure all the process related to documentation has been done as per the guidelines. I have experience in QC of Informed consents and writing protocol deviations if needed as per the study. I have good knowledge of Document submissions to Regulatory.
I have conceptual knowledge of Trial Master File and its components. I assisted CRA’s with their Regulatory visits and maintained site log for the communication purposes. I also communicated with PI’s and CTA’s for study related tasks and Queries.
With ambition to explore my career in clinical research, I recently completed Certification in Health care clinical Research through Wake Tech Community college.
I would like to follow my passion and explore my career in the field of Clinical Research.
Education
Kakatiya University
Work & Experience
Data Coordinator
University of North Carolina
● Responsible for Data entry, ensuring data entered with accuracy and timeliness. ● Responsible for Query Resolution and communicating with other study staff including nurses, lab technicians and other study coordinators. ● Responsible for preparing worksheets for training purposes and training new staff. ● Responsible for communicating with CRA’s, CTAs for study related tasks and maintaining Site Visit logs. ● Responsible for Informed consent review and maintaining site compensation log. ● Performed QC review of Data and identified any data discrepancies and updated in Tracker. ● Responsible for communicating with PI related to SAE’s, DCF’s and other study related tasks. ● Experience working with E-Diaries and maintaining E-Diary compliance log. ● Responsible for reviewing CRF data for accuracy and consistency as well as identify and resolve data discrepancies. ● Created Trackers for Data management activities, reviewed and updated in a timely manner to maintain clean data. ● Assisted in preparation of Source documents/checklists for the study. ● Assisted in SAE and DCF reporting to the sponsor in a timely manner. ● Responsible for Quality control review of EPIC documents. ● Participated in staff meetings and reviewed the agenda under the supervision of Lead Data Manager.
