Pujitha Rao

Experience

• 

  MGM Dental College and Hospital

  Sept 2011 - Sept 2012

  Dental Intern

  I interned at a dental hospital. I have performed the following dental procedures:* Extractions* Root canal therapies* Fixed and removable dentures* Composite and silver amalgam fillings* Scaling and polishing* IOPAs, OPG, lateral ceph* Pediatric extractions

• 

  Canadian Cardiovascular Research Network

  Feb 2014 - Nov 2014

  Research Assistant

  I was working as a Research Assistant at Canadian Cardiovascular Research network from March 2014 to Nov 2014My key responsibilities are as below:• Recruitment of subjects• Obtain consent for the study • Telescreening • Prepare & complete case-report forms • Data entry & review of submitted data• Complete patient follow-up visits over the phone• Assist in hospital visits• Assist in follow visits• Conduct Literature searches• Quality control check

• 

  Cheema research

  Nov 2014 - Feb 2015

  Research Assistant

  I was working at Cheema Research as Research Assistant from Nov 2014 to Feb 2015Description: Cheema Research conducts a number of sponsor based trials in the field of Asthma & allergy for almost a decade. They conduct phase I-IV trialsResponsibilities:• Making source Documents• Pre-Screening for research Subjects• Regulatory Activities

• 

  Peter Munk Cardiac Centre UHN

  Feb 2015 - Dec 2015

  Clinical Research Assistant

  I have been working at Peter Munk Cardiac Centre since Feb 2015 as a Clinical Research AssistantDescription: Peter Munk Cardiac Centre(Toronto General Hospital) performs many cardiac clinical trials, phase II-IV.Responsibilities: • Completion of CRF’s• Data Entry & Review based on GCP & REB guidlines• Quality control check • Prepare & assist in patient follow-up visits

• 

  Scarborough General Hospital Cardiology Research

  Jun 2015 - Oct 2018

  Clinical Research Coordinator

  I am currently involved in 4-5 Studies phase(II-IV), & few chart review studies.I perform the following tasks, as designated by the PI, in order to conduct the clinical study according to FDA regulations and guidelines• Design and maintain organizational tools to conduct the study accurately and in compliance with GCP. Draft SOP's & Source notes for research site.• Ensure the safety and welfare of the study subjects by conducting study visits.• Read the Sponsor's protocol to ensure that all study activities are completed correctly and completely.• Recruit and screen potential study subjects according to the protocol's inclusion and exclusion criteria.• Follow correct informed consent procedures.• Schedule study subjects' visits and perform defined activities of the study completely and accurately.• Report all adverse events and unanticipated problems to the Investigator & IRB in a timely manner.• Maintain adequate and accurate case histories for each study subject and record all observations in the source document and on the Case Report Form (CRF) during the study.• Maintain all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies) • Complete the CRFs for the study accurately, completely, and in a timely fashion. Ideally, CRF are completed at the conclusion of the study visit or within 24 hours post completion.• Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies.• Dispense IP to the subject, as stated in the protocol. • Maintain all required documentation in the research regulatory binder.• Maintain records of each study subjects' status in the study.• Communicate with the Sponsor regarding study activities as necessary. Show less

• 

  Toronto General & Western Hospital Foundation

  Oct 2018 - Jul 2021

  Clinical Research Coordinator

  I am currently involved in 7-8 Studies phase(I-IV), & few chart review studies.I perform the following tasks, -Design and maintain organizational tools to conduct the study accurately and in compliance with GCP. -Manage and report the status of all study agreements, issues and communications with both internal and external sources.-Manage and resolve requested changes from institutions, suppliers, CRO related to Agreements, and from the site Ethics boards related to Informed Consent Form.-Collaborate with Legal Department and external Legal Counsel as necessary to identify solutions related to contract finalization-Determine potential needs for contract amendments and manage amendment execution-Assume responsibilities for all aspects of document tracking and management-Consultation with Compliance to seek approval on specific issues to finalize agreements and Patient Informed Consent-Ensure that the final contract documents and study budgets are consistent with agreements reached during the negotiation process-Attend and engage in scheduled project team meetings as required.-Obtain consent for the study -Recruitment of subjects in drug trials -Prepare & complete case-report forms -Data entry & review of submitted data -Dispensing IP to the subjects -Performing all the study related activities as per protocol-Quality control check -Drafting SOP’s & Source notes -Submissions to IRB/ REB -Phlebotomy for Study related procedures -Conducting Patient visits -Performing tasks as assigned by PI, Sub-I’s. -Organized investigators meeting-Helped support internal and external audits-Drafted SOP’s for the site-Conduct study start -up activities such as overseeing protocol development, CRF development, I---Informed Consent Form development. Show less

• 

  Sunnybrook

  Jun 2022 - Aug 2024

  Clinical Research Project Manager
• 

  Dizzaroo Pvt Ltd

  Mar 2025 - now

  Clinical Research Specialist