Summary
Overview
Work History
Education
Skills
Workshop & Seminar's
Certifications
Interests
Personal Information
Disclaimer
Timeline
Generic

Nishu Upadhyay

Sr. Site Activation Coordinator
Meerut

Summary

Seeking an organization that fosters growth and skill development, leveraging education, experience, and talents to make a meaningful impact. Passionate about contributing to a team in a role that aligns with interests and benefits overall success. Eager to continue learning and expanding skill set while making valuable contributions to a dynamic work environment. Committed to utilizing expertise to drive positive results and achieve mutual success.

Overview

7
7
years of professional experience
7
7
years of post-secondary education

Work History

Sr. Site Activation Coordinator

IQVIA RDS India Pvt Ltd
09.2023 - Current
  • Perform site activation activities in accordance with applicable local and internal regulations, Sops and project requirements and contractual/budgetary guidelines.
  • Perform start up site activations activities according to applicable regulations and sops.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure to complete the EDP packs within timelines.
  • Perform maintenance activities of internal system database and tracking tools with project specific information.
  • Ensure to monitoring measures are in place and implement contingency plan as needed.
  • Review track and follow up the progress the approval and execution of documents, regulatory, ethics, ICF, and investigator pack IP release documents, in line with project timelines.
  • Perform Quality control of documents provided by sites.
  • Provide local expertise to SAM and project team during initial and ongoing project timelines planning.

Clinical Research Associate

Meril Life Science
03.2023 - 07.2023
  • Use Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner for all delegated projects and tasks.
  • Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
  • Perform on-site/ remote monitoring visits, including site qualification, initiation, monitoring, and closeout visits.
  • Execute Monitoring plan, as per GCP and local regulatory regulations. Assist in investigator meetings including preparation, liaison, presentations, problem resolutions, and follow up with site staff as well as vendor and sponsor.
  • Ensure timely submission of protocol and study related documents for EC/IRB approval.
  • Maintain TMF/SMF and review ISF and other regulatory documentation on an ongoing basis in compliance with GCP and local regulatory requirements.
  • Source data verification & Informed consent form review, case report form review, investigational drug accountability, and adverse event review.
  • Ensuring all unused trial supplies are accounted for.
  • Prepare IMV visit reports, filing and collecting trial documentation and reports.
  • Assist Project Manager (PM)/ Assistant Project Manager (APM) in drafting the recruitment strategies and provide inputs towards steps for mitigating recruitment challenges. Motivate investigators in order to achieve recruitment targets.
  • Follow up with sites for resolution of CRF outstanding queries in a timely manner.
  • Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.

Senior Assistant and Research Coordinator

Fortis Memorial Research Institute Guru gram
07.2021 - 03.2023
  • Actively Recruitment/Retention of Subject for Multiple Trials. According to Inclusion/Exclusion Criteria.
  • Conducting on Site Monitoring as well as remote monitoring Visit.
  • Reporting AE/SAE on SUGAM portal.
  • Conducting & coordinating scheduled study visit as well as Unscheduled.
  • Maintaining Site files and Clinical study ISF & related Document's, Involve in ICF process.
  • Work on Multiple rave EDC system- {Medidata, Clinions, Almac, Videoc}, and electronic CRF/paper CRF.
  • Query Resolution / Data base lock data & Cleaning and rectification of data entry in EDC.
  • Participate in close out visit and archival process for study documents.
  • CTA execution and Budget negotiation and invoice part.
  • Preparing EC Dossier and conducting EC Meeting.
  • Conducting SIV and SSV visit for Site selection.

Internship Six Month

Fortis flt.LT Ranjan Dhal hospital
01.2021 - 06.2021
  • Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
  • Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
  • Analyzed problems and worked with teams to develop solutions.
  • Gained hands-on experience in various software programs, increasing proficiency and expanding technical skill set.

Internship

Dayal Seeds Pvt. Ltd.
06.2018 - 07.2018
  • Internship on 'Potato Micro propagation & Mini tuber Production'.
  • Gained valuable experience working within a specific industry, applying learned concepts directly into relevant work situations.
  • Participated in workshops and presentations related to projects to gain knowledge.

Education

MSc - Clinical Research

Jagannath University
01.2019 - 01.2021

B.Sc. - Biotechnology

MIET
01.2016 - 01.2019

Intermediate - undefined

Vansthali Public School
01.2015 - 01.2016

High School - undefined

Growell Public School
01.2014 - 01.2015

Skills

  • MS office
  • Quick learner
  • Teamwork and collaboration
  • Adaptability and flexibility
  • Presentations
  • Clinical On-site Monitoring
  • Interpersonal and social skills
  • Multitasking and organized

Workshop & Seminar's

  • Attended two days National Workshop on 'Environmental Restoration by Applying Metagenomics in Bioremediations' organized by School of Biotechnology GBU NOIDA & Chaperon Biotech Pvt. Ltd., Kanpur.
  • Attended One Day Workshop on 'Food Adulteration Analysis & QC' in Rapture Biotech International Pvt. Ltd. NOIDA.
  • Attended International Mini Symposium on Biotechnology in Medical Research.
  • Attended conference on IPR talk in Ansal University, GURUGRAM.

Certifications

  • Coursera - COVID-19: What you all need to know.
  • ICH-GCP by NIDA (National Institute on Drug Abuse).
  • Done CCC (Course on Computer Concept) from NIELIT.

Interests

Travelling

Personal Information

  • Date of Birth: 12/08/1998
  • Gender: Male
  • Nationality: Indian
  • Language Proficiency: English/Hindi.
  • Marital Status: Unmarried

Disclaimer

I hereby declare that all the above information is true to the best of my knowledge.

NISHU UPADHYAY

Timeline

Sr. Site Activation Coordinator

IQVIA RDS India Pvt Ltd
09.2023 - Current

Clinical Research Associate

Meril Life Science
03.2023 - 07.2023

Senior Assistant and Research Coordinator

Fortis Memorial Research Institute Guru gram
07.2021 - 03.2023

Internship Six Month

Fortis flt.LT Ranjan Dhal hospital
01.2021 - 06.2021

MSc - Clinical Research

Jagannath University
01.2019 - 01.2021

Internship

Dayal Seeds Pvt. Ltd.
06.2018 - 07.2018

B.Sc. - Biotechnology

MIET
01.2016 - 01.2019

Intermediate - undefined

Vansthali Public School
01.2015 - 01.2016

High School - undefined

Growell Public School
01.2014 - 01.2015

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Nishu UpadhyaySr. Site Activation Coordinator