Dr. Sai Prashanth Sadasivuni

Experience

• 

  Kadiyala Hospitals

  Sept 2020 - Jul 2021

  Trainee DMO

  Worked as a duty doctor in urology and general medicine, had attained experience in emergency medicine and I had learned some procedures related to urology and general medicine.

• 

  GALAXY CR Services

  Aug 2021 - Nov 2022

  Sr. Clinical Research Coordinator

  *Assist Principal Investigator or Sub-Investigator during the consent process and give preliminary assistance.*Provide the site related responses and facilities available at the site during site feasibility and take the opinion about study which specifies about the study FQs. *Perform start-up rated activities like communicating with sponsor representatives and BD team about upcoming projects.*Responsible for identification and collection of necessary documents in order to check Feasibility of Site.*Prepare the documents which require for Site Qualification visit.* Liaise to ensure compliance with standard protocol, regulatory requirement,s and ICH GCP obligations in assigned aspects of clinical site monitoring. * Write, follow, and resolve clinical queries and issues during and post monitoring visits. * Have adequate knowledge in study document specialization i.e., maintaining and store document into a records system.* Maintain the source document and Filling Case Report Forms (CRF’s) and Electronic Data Capture (EDC) in a timely manner. * Communication with CROs or Sponsor or CLS vendors as required. * Preparing and submitting subsequent study related documents and notifications during ongoing trial to Institutional Ethics Committee (IEC).* Randomized the patients through IWRS (Intellectual Web Response System).*Maintaining source documents in an appropriate manner. *Also served as a primary communicator between Investigator, CRO and Sponsor Show less

• 

  Pharmazone

  Dec 2022 - Jun 2023

  Clinical Research Associate

  * Skilled in protocol, CRF(Paper and eCRF) IB, ICF review and SDV (Source Data Verification).* Had experience in eTMF review* Had experience in onsite Monitoring visits (OSV) and Remote visits of 07 months and have done 25+ onsite individual monitoring for 02 clinical trials.* Had an experience of onsite and remote Site Initiation Visit (SIV)* Perform SQV(Site Qualification Visit) SIV (Site Initiation Visit), SMV (Site Monitoring Visit), SCV (Site Close Out Visit), RMV(Remote Monitoring Visit).* Had experience in global and Indian clinical phase III and IV trials.* Provide training on the Company SOPs to new joiners.* Handled all the end-to-end CRA responsibilities.* Handled an oncology Biosimilar trial. * Ensured timely completion of the data entry with all the sites and reviewed the data remotely to ensure the safety of the trial subjects.* Managed well in the plan of monitoring visits based on the risk and the patient pool at the site.* Handled invoice reviews promptly with coordination with sites.* Coordinated with sites and the other vendors for the shipment of the IP and the central lab Show less

• 

  IQVIA Asia Pacific

  Jul 2023 - now

  Associate Central Monitor

  * Engaged in 02 Oncology global studies Phase II & Phase III. * Evaluate the quality and integrity of study, site practices, country regulation where related to the proper conduct of the protocol and adherence to applicable regulations.* Manage the progress of assigned studies by tracking every aspects like, Ethics Committee notifications, Site level trends, recruitment & enrollment, eCRF completion as per the Turn Around Time (TAT), Query generation and resolution.* Perform risk assessments and management responsibilities through out the project, including Site health analysis, Site process evaluation.* Essential aspects of effectively developing a project subject recruitment strategy on a site-specific basis. Recommend to the CRA methods to improve the site's recruitment plan in accordance with project requirements to increase predictability. Support the CRA in monitoring the progress of subject recruitment at each site.* Liaise to ensure compliance with standard protocol, SOP’s, regulatory requirement. * Performing Remote Data Review (RDR) on daily basis where if required create clinical queries and provide the suggestions.* Presenting the overall study and country level trends and Issues with sponsor hierarchy COL(Country operations leads) or CSM (Country study Manager) or GSM (Global Study Managers) or vendors as required in monthly bases. * Worked on different e-Tools like PDMS (Protocol deviation Management System), EDC (Imedidata & Oracle RDC), IxRS (ALMAC and Oracle RDC), eTMF(Veeva vault), SUSAR portal and CTMS (Oracle) Show less