Summary
Overview
Work History
Education
Skills
Skills
Additional Information
Languages
Timeline
Generic

NAGAVAISHNAVI IRIVINTI

Summary

To obtain a professional career, with a well-established company, that may benefit from my proven skills and attributes.

Overview

6
6
years of professional experience

Work History

Central Monitoring Assistant

IQVIA RDS PRIVATE LIMITED
08.2022 - Current
  • Responsible for remote monitoring and site management of Phase II-IV clinical research studies, conducting all types of remote monitoring visits, inclusive of monthly site management calls (SMCs).
  • Maintains effective communication with sites, establishing solid relationships with Investigators and all other site staff.
  • Assures compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
  • Critically evaluates adequacy of Investigator sites (qualifications, facilities, equipment and performance).
  • Plans and conducts study initiation calls for Investigator sites.
  • Applies planning techniques for SMCs to ensure efficient and effective remote monitoring.
  • Plans and conducts study close-out calls for Investigator sites.
  • Manages and prioritizes workload effectively.
  • Completes and submits monitoring call reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work.
  • Maintains awareness of key study performance indicators for own sites.
  • Updates study and patient status information.
  • Documents and tracks the resolution of all outstanding site-specific protocol-related, quality or ICH/GCP compliance issues from contact to contact.
  • Manages assigned sites via inbound and outbound telephone calls/emails and oversees study site activities to ensure the integrity of clinical data.
  • Ensures sites have the required study training and are compliant with the protocol, regulatory guidelines and study procedures.
  • Remotely reviews electronic data completed by sites and assists the site in resolving queries and/or other identified data issues.
  • Ensures eTMF is current and up to date including items such as telephone contact reports (TCRs), Essential Documents, etc.
  • Attends Investigator meetings, clinical monitoring staff meetings, project team meetings and clinical training sessions.
  • Builds upon a basic understanding of the drug development process, Good Clinical Practices (GCP) and relevant regulations.
  • Monitors site performance metrics and patient enrolment and with guidance implements action plans for sites not meeting expectations.
  • Seeks guidance to resolve complex issues.
  • Attended Investigator Meetings and presented to site staff.

Summer Intern

Amity University Of Molecular Medicine
05.2021 - 06.2021
  • Project title - In silico drug designing for breast cancer through targeting fatty acid synthase. Drug designing is done by Molecular docking technique.

Research Trainee

Genomix Carl Private Limited
07.2020 - 08.2020
  • Performed Rt-PCR tests for the detection of the COVID-19 virus. Sample collection, segregation, RNA isolation, Rt-PCR, Data interpretation was performed.

Summer Intern

Agri Biotech Foundation
04.2018 - 05.2018
  • Project title- plant root exudates stimulate cross-talk between bacteria and plant. Root Exudates shape the rhizosphere microbial community. The plant used- Maize, Bacteria used- Pseudomonas putida.

Education

Master of Science - Molecular Biology

Bangalore University
Bangalore
06.2021

Bachelor of Science - Microbiology, Botany And Chemistry

Rayalaseema University
Kurnool, AP, India
04.2016

Skills

  • ICF and GCP Guidelines
  • Standard Operating Procedure (SOP)
  • Risk Based Quality Monitoring(RBQM)
  • Site and Study level risk identification and mitigation, Protocol, Trial Monitoring Plan
  • Systems: Clinical Trail Management System (CTMS)
  • Medidata Rave
  • eTMF
  • IXRS analysis
  • CM dashboards, Data Management tool, Issue management tool, Site management tool, Third party Vendor Portals, Presentation Skills, Witten and Verbal Communication with clients/sponsor and stakeholders
    Microsoft Skills: Microsoft Excel, Microsoft PowerPoint, Microsoft word
  • Time management, Client focus, Communication and Study Team Management

Skills

administrative support, basic, clinical research, oral communication, Excellent interpersonal skills, content, Critical Thinking, client, Customer service experience, database, drug development, GCP, Management skills, Meetings, Monitors, Organizational skills, personnel, PRESENTATIONS, product testing, quality, quality control, Regulatory Affairs, regulatory documents, Siebel, SOP, telephone, written

Additional Information

  • COMMUNITY SERVICEAmerican Red CrossDisaster Action Team-Captain

Languages

English
Advanced (C1)
Hindi
Intermediate (B1)
Telugu
Bilingual or Proficient (C2)
Kannada
Beginner (A1)

Timeline

Central Monitoring Assistant

IQVIA RDS PRIVATE LIMITED
08.2022 - Current

Summer Intern

Amity University Of Molecular Medicine
05.2021 - 06.2021

Research Trainee

Genomix Carl Private Limited
07.2020 - 08.2020

Summer Intern

Agri Biotech Foundation
04.2018 - 05.2018

Master of Science - Molecular Biology

Bangalore University

Bachelor of Science - Microbiology, Botany And Chemistry

Rayalaseema University

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NAGAVAISHNAVI IRIVINTI