Pawan Pratap Yadav
Clinical Research Associate
Ahmedabad,Gujarat
Summary
Aspiring Candidate seeking a successful career in the competitive and
challenging environment in an esteemed institution.
Overview
5
5
years of post-secondary education
2
2
years of professional experience
Work History
Clinical Research Associate
Pharmazone
Ahmedabad, Gujarat
06.2021 - Current
- Overall site management of clinical studies ensuring that project is progressing according to standards Protocol, SOP, GCP and other applicable guidelines.
- Ensure the communication to site about the project Scope pf work, time line and project goals, technical information and input from project Manager throughout the project.
- Preparation of site visits report/monitoring report including, site qualification, Site Initiation, site monitoring, site closeout, etc.
- To perform Site Qualification, visit and to prepare report within stipulated time.
- To perform Site Initiation, visit which include ensuring each site has the trial materials and training of site staff to trial specific and industry standards with Project Manager and to prepare reports.
- Interim monitoring visit trial conduct at site throughout its duration which will involve visiting the study site at predefined interval to assess that the study ls being done in accordance with the protocol and monitoring plan and that the human right is not violated source data verification collecting completed CRF from sites.
- To perform site closeout to ensure that site has resolved all data queries, availability of updated site file, patient/subject file and reconciliation of investigational product.
- Ensure Communication with sites for ethics committee notification of serious adverse event, study progress, protocol deviation and safety reporting.
- Prepares the project for archival as specified by contract at the end of study completion.
Clinical Research Coordinator
Eisai pharmaceuticals
Gurgaon, Haryana
08.2020 - 06.2021
- Supports study-related committees by attending meetings, preparing meeting minutes, and maintaining all committee-related documents.
- Preparation of Performs, filling the Patients information Collecting Data From Other Departments like Ortho, Neurology etc.
Supports the Medical Affairs and Medical Operations departments and staff. - Collecting Data From Other Departments like Ortho, Neurology etc.
- Supports the Medical Affairs and Medical Operations departments and staff.
- Preparing Research Papers, making Case Study Report, Patient Enrollment etc.
- Performs Files Creation , Recreation and maintenance (Paper and electronic).
- Initiates and Follows up with Study Sites as necessary.
- Assists Medical Affairs Scientists with review of medical
data listings. Case Report Form (CRF) line and lab listings,
and medical coding, highlights areas for medical review.
Clinical Research Coordinator (INTERNSHIP)
Klinera Global
Delhi, Delhi
01.2020 - 08.2020
- Patient File Management, Ethics Committee Meetings Preparation of Agenda, Minutes Etc.
- Patient Information Maintenance in Electronic Data Capture (Medidata Rave).
- Preparation of Feasibility.
- Conducting Site Selection Visit.
- Preparing Source documents Filing Performs, Patient Screening, Blood Sampling, A/V Consenting Documentation Archival ETC.
Education
Master of Science - Clinical Research
Amity University
Haryana 07.2018 - 07.2020
Bachelor of Science - Zoology, Botany, Chemistry
Jiwaji University
Gwalior 07.2014 - 07.2017
Skills
Coordinating site operations
Timeline
Clinical Research Associate
Pharmazone
06.2021 - Current
Clinical Research Coordinator
Eisai pharmaceuticals
08.2020 - 06.2021
Clinical Research Coordinator (INTERNSHIP)
Klinera Global
01.2020 - 08.2020
Master of Science - Clinical Research
Amity University
07.2018 - 07.2020
Bachelor of Science - Zoology, Botany, Chemistry
Jiwaji University
07.2014 - 07.2017
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