Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Shravani Kanduri

USA

Summary

Experienced clinical research professional with progressive experience in phase I-IV clinical trials across neurology, dermatology, oncology, and diabetes. Strong background in regulatory compliance, study coordination, site management, and clinical trial documentation. Adept at maintaining Trial Master File (TMF), Clinical trial management systems (CTMS), and Electronic data capture (EDC) to ensure smooth trial operations. Passionate about supporting research teams and improving trial efficiency while adhering to ICH-GCP, FDA, and IRB regulations.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

Healthy U Clinics
04.2023 - Current
  • Produced accurate documents and reports while maintaining a compassionate relationship with study participants
  • Coordinated the day-to-day activities of the research study team, specifically carrying out the research clinical protocol
  • Screened and consented study participants for various studies
  • Took vital signs and recorded medical history and prior medical events
  • Adaptive clinical research coordinator skilled in multi-team management works with the principal investigator and medical staff to correlate hospital procedures with clinical trials and reports to medical personnel during off-site research trials
  • Processed blood samples and sent them to the designated laboratory
  • Reported different ae and sae and appropriately documented
  • Successfully communicated with the sponsor side's other team members as well as the CRA
  • Ensured that GCP rules were followed in the clinical studies
  • Abetted with patient visits, documentation, CRF completion, data queries, and monitoring visits
  • Helped maintain accuracy with the patient database, including data entry and updating existing patient file

TMF Reviewer I

Parexel
12.2021 - 07.2022
  • Maintains an overview of the agreed planning, proactively providing status updates and notifying the study team and TMF IR Specialist of trends
  • Assisted in IRB/EC submissions, coordinating approvals, and maintaining regulatory records
  • Assist in the study initiation process, contributing to the creation of the TMF Plan, TMF Oversight Plan, and expected document lists and coordinating archival/transfer activities as required
  • Prepared study files for investigator sites and ensured document accuracy
  • Collaborate with the Project Lead, Clinical Study teams, and CRO to ensure a high level of quality and maintain compliance with TMF through the study life cycle to meet departmental and project goals
  • Managed essential trial documentation, including protocol amendments and safety reports
  • Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks
  • Maintains an overview of the agreed planning, proactively providing status updates and notifying the study team and TMF IR Specialist of trends
  • Processes site payments for clinical studies
  • Oversee TMF user access management as required
  • Conduct milestone reviews for clinical trials, ensuring that all milestones are met according to the study timeline and protocol
  • Stays flexible and always looks for proactive, responsible solutions to ensure client satisfaction
  • Provides feedback to PS/FL superusers in CRS technology to enable enhanced systems, tools, and processes
  • Create and manage team meetings, develop corresponding agendas, and draft meeting minutes
  • Maintains the TMF for ongoing studies according to Parexel SOPs or contractual obligations to sponsor by performing completeness checks/Milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria
  • Conduct comprehensive reviews of study-related or essential documents to ensure they are complete and compliant with the study protocol and relevant regulatory requirements
  • Proactively cooperate with LM and FLs on the project's TMF tasks
  • Understand how their own role and expertise impact TMF quality and timeliness
  • Takes proactive measures to prepare a study for audit
  • Facilitates internal and external TMF Audits
  • Prepares eCRF CDs and participates in eCRF process as defined in the relevant manuals and SOPs
  • India

Clinical Trial Assistant

LabCorp drug development
01.2018 - 11.2021
  • Complete required training according to required timelines
  • Complete day-to-day tasks, ensuring quality and productivity
  • Create the study TMF Index as directed by the PM
  • Assist in tracking and follow-up of action items
  • Appropriately maintain the project and technical documentation
  • Perform checks to ensure the quality of work completed. Maintain Quality control procedures, including periodic basic quality, Inventory, and completeness checks to ensure accurate maintenance of files
  • To acquire knowledge and skills to process study documents by client and study requirements as per study-specific processes, where applicable
  • Provided support to the clinical trial team in organizing, planning, and executing clinical trials, ensuring adherence to standard operating procedures (SOPs), good clinical practice, and relevant regulatory standards
  • Draft the TMF Plan, incorporate revisions following review, produce the final version, and distribute it to the study team
  • Identify any gaps in documentation and inconsistencies, then communicate with the study team to address and resolve them
  • Participate in the conduct of quality review (QC) of the TMF for each assigned study before the study milestone audit check and provide innovative solutions
  • Follow up with Clinical Research Associates for outstanding issues and resolve them on time
  • Assist in the document receipt and processing, which may include document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams, and archiving for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration
  • Participate in client audits as necessary. Assist the study startup teams with tasks required for site start-up activities
  • Other duties/activities as assigned by the study management team, but not limited to:
  • Manage study documents such as study level, country level, and site level
  • Maintain study databases (CTMS)
  • Support study team in e-TMF management activities.

Education

Master of information technology -

university of Cumberland’s
05.2023

Bachelor of pharmacy -

Vaageswari college of pharmacy
05.2019

Skills

  • Case report management
  • Knowledge in the handling of electronic health record (EHR) systems
  • Clinical trial coordination and Site management
  • Regulatory compliance (ICH-GCP, FDA, IRB/EC submissions)
  • Trial master file (TMF) management
  • Clinical document management
  • Clinical Trial Management Systems (CTMS)
  • EDC
  • Patient recruitment, Screening, Retention
  • Budget management
  • Adverse event (AE) and Serious Adverse event (SAE) reporting
  • Investigator coordination
  • Data collection
  • Monitoring
  • Query resolution
  • Audit and Inspection readiness
  • Protocol adherence
  • Compliance monitoring
  • Investigator meeting coordination
  • Site training coordination

Certification

Nida Clinical Trial Network Good Clinical Practice

Timeline

Clinical Research Coordinator

Healthy U Clinics
04.2023 - Current

TMF Reviewer I

Parexel
12.2021 - 07.2022

Clinical Trial Assistant

LabCorp drug development
01.2018 - 11.2021

Bachelor of pharmacy -

Vaageswari college of pharmacy

Master of information technology -

university of Cumberland’s

Similar Profiles

CREATE PROFILE
Shravani Kanduri