Open To Work
SRIDIVYA R
Summary
Experienced Clinical Research professional with 3+ years in clinical trials, study start-up, and regulatory documentation. Skilled in managing eTMFs, collaborating with CRAs, and supporting compliance across Phases I–III. Proficient in clinical systems like Veeva Vault, CTMS, and Medidata. Known for strong attention to detail, adaptability, and a results-driven approach. Seeking to transition into a Home-Based CRA role to contribute to high-quality, patient-focused clinical trial operations.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Study Start-Up Clinical Administrator
AstraZeneca
02.2024 - Current
- Managed the collection, review, and tracking of essential regulatory and ethics documents to support Site Initiation Visit (SIV) readiness and on-time activation.
- Maintained inspection-ready Trial Master Files (eTMF) using Veeva Vault, ensuring document accuracy, version control, and audit preparedness at all times.
- Facilitated cross-functional communication between CRAs, medical monitors, regulatory teams, and vendors to resolve start-up delays and improve timelines.
- Ensured compliance with AstraZeneca’s governance frameworks, SOPs, and regulatory standards, supporting audit and inspection readiness throughout the start-up phase.
- Demonstrated proficiency in using clinical trial systems such as CTMS, Veeva Vault, Medidata, and SharePoint to streamline documentation and workflow processes.
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. SharePoint etc) and support others in the usage of these systems.
- Managed and contribute to coordination and tracking of study Start-Up materials and equipment.
- Coordinated with global start-up activities across Phase I–III oncology trials, ensuring timely site activation in compliance with ICH-GCP, regulatory guidelines, and company SOPs.
- Coordinate administrative tasks during the study Startup process, audits and regulatory inspections, according to company policies and SOPs.
Clinical Data Assistant (Contractor)
One US Technology, LLC
09.2023 - 01.2024
- Supported clinical data management teams in the collection, review, entry, and validation
- Of clinical trial data across multiple phases.
- Performed data discrepancy management by reviewing queries, communicating with sites, and updating data management systems accordingly.
- Collaborated with cross-functional teams (clinical operations, medical monitors) to resolve data issues.
- Utilized industry-standard tools such as Medidata Rave and Veeva CDMS, for data entry and tracking.
- Support the completion of all Clinical Data Management owned deliverables in order to achieve defined business goals.
Clinical Research Intern
Stamford Hospital
08.2022 - 12.2022
- Conducted patient enrollment, visit scheduling, and source data verification for infectious disease and public health trials.
- Verified CRF entries against medical records and informed site staff of data inconsistencies.
- Participated in on-site and remote monitoring visits, prepared study documents, and ensured protocol compliance.
- Supported internal audits and monitor visits by ensuring site files were organized, current, and GCP-compliant.
Dentist & Health Educator
Sree Sai Dental Hospital
05.2018 - 05.2021
- Delivered comprehensive dental care, including diagnosis, treatment, and preventive services.
- Conducted behavioral assessments and provided counseling to improve oral health habits.
- Led community outreach and oral health education campaigns promoting hygiene and disease prevention.
- Utilized evidence-based therapies such as Cognitive Behavioral Therapy (CBT) to manage dental anxiety.
- Collaborated with multidisciplinary teams to develop holistic patient care plans.
- Maintained accurate and compliant patient records in line with regulatory standards.
- Advocated for patient access to healthcare resources and coordinated referrals as needed.
Education
Master of Public Health -
University of New Haven
New Haven, CTPost Graduate Diploma - Clinical Research & Management
CLINI INDIA
IndiaBachelor of Dental Surgery - undefined
Dr. NTR University of Health Sciences
IndiaSkills
- Veeva Vault eTMF CTMS SharePoint
- Medidata RAVE CDMS
- Microsoft Excel, Word, PowerPoint
- Oncology & Public Health Trial Experience
- Basic Statistical Tools
- Good clinical practice
- Data management expertise
- Regulatory compliance awareness
Certification
- Licensed Dentist - 2018-2021 (India)
Languages
English
Full Professional
Hindi
Full Professional
Telugu
Native or Bilingual
Tamil
Elementary
Timeline
Study Start-Up Clinical Administrator
AstraZeneca
02.2024 - Current
Clinical Data Assistant (Contractor)
One US Technology, LLC
09.2023 - 01.2024
Clinical Research Intern
Stamford Hospital
08.2022 - 12.2022
Dentist & Health Educator
Sree Sai Dental Hospital
05.2018 - 05.2021
Post Graduate Diploma - Clinical Research & Management
CLINI INDIA
Bachelor of Dental Surgery - undefined
Dr. NTR University of Health Sciences
Master of Public Health -
University of New Haven