Sreeja Vydhyam
Brantford,ON
Summary
Accomplished Clinical Research Associate with 2 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
2
2
years of professional experience
Work History
Clinical Research Associate - I
IQVIA
09.2019 - 11.2021
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Leveraged [Type] knowledge, expertise and problem-solving techniques to resolve investigative site issues.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Established drug trial methodologies and procedures to support business and clinical trial endeavors.
- Supported development and delivery of department training to maximize success of clinical research.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Education
Healthcare Administration And Service Management
Conestoga College Institute of Technology And Advanced Learning
Brantford, ON04.2023
Pharm. D (Doctor of Pharmacy) -
Kakatiya University
Warangal, India06.2019
Skills
- Patient Safety
- Data Collection
- Quality Control
- Status Reporting
- Data Evaluation
- Clinical Research Monitoring
- Reviewing Data Standards
- Site Investigation Reports
- Case Report Management
- Clinical Data Management System (CDMS)
- Troubleshooting
VOLUNTEERING
PVPI, MGM Hospital, Warangal, India
Actively Reported 15 ADR's to PVPI
Additional Information
TRAININGS AND WORKSHOPS:
GCP certified by NIDA Clinical Trials Network
Timeline
Clinical Research Associate - I
IQVIA
09.2019 - 11.2021
Healthcare Administration And Service Management
Conestoga College Institute of Technology And Advanced Learning
Pharm. D (Doctor of Pharmacy) -
Kakatiya University
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