Summary
Overview
Work History
Education
Skills
Languages
Technical Skills
Audit and Inspections
Timeline
Generic

Sakshi Wandhare

Nagpur

Summary

Motivated and methodical clinical research professional arranging sites, operations and regulatory functions. Proficient in data capture procedures and action planning. Seeking a dynamic, growth-oriented position.

Overview

3
3
years of professional experience

Work History

Sr. Clinical Research Associate

Ipca Laboratories ltd
Mumbai
01.2024 - Current
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Prepared reports summarizing findings from monitoring visits.
  • Coordinated shipment of investigational product samples to sites.
  • Ensured timely submission of required documents from investigative sites.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Monitored subject enrollment and tracked dropout details.

Clinical Research Coordinator

Health Care Global Pvt Ltd
Nagpur
08.2022 - 01.2024
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Developed and maintained accurate and timely study databases.
  • Reviewed CRFs for completeness and accuracy before database entry.

Trainee Clinical Research Coordinator

Sun Services Pvt ltd
Pune
06.2021 - 08.2021
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Provided technical support to investigators regarding data entry into electronic case report forms.
  • Performed ongoing monitoring visits at participating sites according to established schedules.
  • Developed and maintained clinical trial documents, such as protocols, case report forms, and informed consent forms.
  • Managed drug supply inventory for multiple trials.
  • Tracked adverse events reports from participating sites throughout the course of each trial.
  • Participated in internal audits of clinical studies when required by sponsors or regulatory agencies.
  • Took vital signs and collected medical histories as part of study protocols.

Education

Post Graduation Diploma in Clinical Research And Pharmacovigillence -

MITCON
Pune
01-2022

Master of Science - Microbiology

Kamla Nehru College
Nagpur
06-2019

Bachelor of Science - Microbiology And Bacteriology

K. R. Pandav College
Nagpur
08-2017

High School Diploma -

Vidharbha Buniyadi Junior College
Nagpur
05-2014

High School Diploma -

Bhagwati Girls Highschool
Nagpur
05-2012

Skills

  • Patient safety
  • Monitoring visits
  • Project management
  • Project monitoring
  • Recruitment strategies
  • Site monitoring
  • Clinical documentation
  • Report writing

Languages

Marathi
First Language
English
Upper Intermediate (B2)
B2

Technical Skills

· Worked on software RAVE iMedidata, OC-RDC, Clinion, agcapture, Clinspa, IXRS Almac, Cellcarta, Octalsoft, Clindox, Labcorp, ePIP.

· MS Office- MS Excel, MS Word, MS Power point, EMR

· Training's- NIDA, GCP guidelines

Audit and Inspections

· 1 FDA Inspection

·  1 Sponsor Audit

Timeline

Sr. Clinical Research Associate

Ipca Laboratories ltd
01.2024 - Current

Clinical Research Coordinator

Health Care Global Pvt Ltd
08.2022 - 01.2024

Trainee Clinical Research Coordinator

Sun Services Pvt ltd
06.2021 - 08.2021

Post Graduation Diploma in Clinical Research And Pharmacovigillence -

MITCON

Master of Science - Microbiology

Kamla Nehru College

Bachelor of Science - Microbiology And Bacteriology

K. R. Pandav College

High School Diploma -

Vidharbha Buniyadi Junior College

High School Diploma -

Bhagwati Girls Highschool

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Sakshi Wandhare