Summary
Overview
Work History
Education
Skills
Certification
Personal Information
Publications
Achievements And Awards
Timeline
Generic

SUNAKSHI RASTOGI

Clinical research data co-ordinator
Bengaluru

Summary


Research data professional with progressive experience in Phases I-IV clinical trials across therapeutic areas including oncology, endocrinology, cardiology, neurology, ophthalmology, and infectious diseases. Strong analytical skills and expertise in data management, coordination, and analysis. Proven ability to collaborate effectively within teams, adapt to changing needs, and deliver impactful results. Demonstrated leadership in managing teams, audits, and cross-functional collaboration with a focus on regulatory compliance, data quality, integrity and operational excellence. Skilled in Power Bi and data visualization tools, AI tools for digital trials. Known for reliability, precision, and strong commitment to achieving project goals.

Overview

9
9
years of professional experience
8069
8069
years of post-secondary education
1
1
Certification
2
2
Languages

Work History

Clinical Research Data Coordinator

ConcertAI
Bengaluru
10.2023 - Current
  • Review project specific documents, to develop familiarity with project goals and with the data abstraction tasks in each project.
  • Perform prescreening activities using the DTS e Screening tool to determine likely eligibility for a clinical trial.
  • Undertake medical record reviews to populate and annotate EMR data for eCRF entry.
  • Support site use of the DTS and DTS system interactions with target EDC systems.
  • Detect issues related to data capture, collection or management and suggest solutions.
  • Assist in investigating incomplete, inaccurate, or missing data and documents to ensure accuracy and completeness of data ingestion for AI Machine Learning and AI Modeling.
  • Provide subject matter expertise on clinical trial data entry into EDC systems utilized by sites and for leveraging on internal projects.
  • Managing with partner vendors, internal product and engineering teams, as well as IT and clinical research informatics staff to suggest improvements in hardware and software functionality for Clinical Data Coordinator and Site Staff workflows.
  • Interacting internally with the other Data Coordinators, Clinical Project Managers, Director of Clinical Delivery and other DTS staff regarding ongoing and planned projects.
  • Responsible for organizing study related material and attend study relevant meetings with clinical research site staff and support with use of DTS modules.
  • Use other resources as needed to gain the knowledge required to perform Clinical Data Coordinator work on new projects.
  • Share EDC eCRF and data query workflow knowledge and project-specific procedural knowledge with other Clinical Data Coordinators as needed.
  • Maintain a professional approach respecting the dignity and confidentiality of patients, associates, managers, and vendors.
  • Performing UAT for oncology trials.
  • Working as Remote CRA for sites in US.

Senior Research Fellow

AIIMS
New Delhi
03.2019 - 11.2022
  • Responsible for the highest standard of conduct of the trial by providing consultation to the study team on the quality-related methods.
  • Managed a team of 5 to generate maximum output.
  • Maintained quality compliance at the site to ensure adequate process and ethical conduct.
  • Ensured process compliance by conducting internal reviews and updating existing processes (SOPs, templates) and guidance.
  • Provided training to site staff on ICH and local regulations.
  • Conducted training for new staff, addressing process gaps and ad-hoc training as required.
  • Experienced in patient identification, screening, and recruitment.
  • Managed study-specific data, capturing it electronically in EDC platforms like Oracle, Rave.
  • Managed data to ensure high accuracy and transparency, avoiding discrepancies in clinical data.
  • Performed SAE data collection, review, and reconciliation as per ICH-GCP guidelines.
  • Identified protocol deviations in the data source and resolved them per guidelines.
  • Supported each clinical study by ensuring data management plans and handling activities were done to meet project and protocol deadlines.
  • Train the new joiners on processes and mentoring for onboard training till signing.

Site Executive

Cytespace Pvt. Ltd.
New Delhi
05.2016 - 03.2019
  • Provided administrative support to clinical projects with minimal supervision from Clinical Team Leads and/or other designated clinical team members.
  • Maintained and periodically reviewed the Trial Master File for quality, accuracy, and completeness.
  • Coordinated and facilitated clinical trial activities at the site, ensuring compliance with protocol, applicable GCP guidelines, and local regulations.
  • Screened & recruited study subjects, ensuring patient compliance.
  • Managed drug supply, lab kits, and investigational products.
  • Maintained source documentation, submitted reports to ethics committees.
  • Received awards for outstanding performance and participated in clinical research events.
  • Supporting patient awareness, training or other events at site.

Education

Clinical Data Management (Advanced) -

IGMPI
New Delhi
2025

PG Diploma in Clinical Research -

Socrates School of Health
New Delhi
2016

M.Sc. - Microbiology

MM University
Ambala
2015

B.A.Sc. (H) - Instrumentation

Delhi University
New Delhi
2013

Skills

MS Office Suite

SOP Development

Quality & Compliance Monitoring

Strong Communication

Team Leadership

Time Management

Analytical Problem-Solving

Multitasking efficiency

Data quality assurance

Project management experience

Data visualization techniques

Research data collection

Teamwork

Problem-solving abilities

Leadership skills

Site management

Trial management

Excellent communication

Decision-making

Certification

GCP certified, CITI PROGRAM, 10/14/24, 10/15/25

Personal Information

  • Date of Birth: 12/29/90
  • Gender: Female
  • Marital Status: Married

Publications

Book Chapter: #6, "Bio-colours: An Insight into Production, Application, Stability and Regulation.", Rastogi S, Sharma C, Sharma AK, Aggarwal H, Beniwal V, 2016, Sharma C, Sharma AK, Aneja KR, Frontiers in Food Biotechnology Nova Publishers, USA

Achievements And Awards

  • Outstanding Coordinator Award, Cytespace Pvt. Ltd., 2017
  • Certificate of Excellence, Socrates School of Health, 2016
  • Recognized for achieving 100% query resolution compliance in 3 consecutive studies.
  • Contributed to the successful Audit of a pivotal trial with no major findings.

Timeline

Clinical Research Data Coordinator

ConcertAI
10.2023 - Current

Senior Research Fellow

AIIMS
03.2019 - 11.2022

Site Executive

Cytespace Pvt. Ltd.
05.2016 - 03.2019

Clinical Data Management (Advanced) -

IGMPI

PG Diploma in Clinical Research -

Socrates School of Health

M.Sc. - Microbiology

MM University

B.A.Sc. (H) - Instrumentation

Delhi University

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SUNAKSHI RASTOGIClinical research data co-ordinator