Krishnaveni S
Summary
Over 1.5 years of experience as Clinical Research Coordinator with hands-on experience in enrollment of subjects, Screening, protocol compliance, Informed consent, data collection, and regulatory documentation. Holds a Master’s in Health Informatics and accurate data using electronic data capture (EDC) systems, GCP, CRFs and HIPAA. Skilled in working across sites, maintaining data accuracy, ensure patient safety and supporting high-quality, patient-centered research.
Overview
1
1
years of professional experience
Work History
Clinical Research Coordinator
BridgeBio
09.2023 - Current
- Experience in implementing the different clinical trial study protocols by collaborating with Principal Investigators (PI), department supervisors and clinical managers in all phases to ensure the proper executions across teams.
- Experience in patient screening, enrollment by following strict protocol inclusion/exclusion criteria, follow-up for clinical trials by following according to the protocol compliance and ethical guidelines.
- Experience in Preparing and maintain essential study documentation, including protocol amendments, case report forms (CRFs), and electronic data capture (EDC) systems, ensuring accuracy and completeness.
- Experience in preparation of regulatory documentation including IRB submissions, protocol amendments, and IND safety reports in compliance with the FDA institutional regulations for timely approvals and study readiness.
- Working experience in conducted site visits monitoring, facilitated audits and performed the quality control checks to assess the data integrity, regulatory compliance.
- Engaged in the ongoing professional development by attending meetings, workshops, seminars and conferences.
- Maintained study-specific logs, patient binders, and regulatory binders, ensuring audit-readiness and documentation accuracy.
- Maintained confidentiality of protected health information (PHI) as per HIPAA regulations and reported any violations.
- Hands on experience in the web based platforms and tools like MS Word, Excel accurate documentation and reporting processes.
Associate Consultant
Flairbee Corporation
09.2016 - 03.2021
- Company Overview: India
- Assist in analyzing client requirements and developing IT solutions.
- Conducted research on emerging technologies and best practices.
- Experience with databases, perform data analysis, and generate reports.
- Provide regular updates and communicate project progress.
- My responsibilities include managing and overseeing clinical data, involving accurate data entry and maintenance, ensuring data quality and validation, and generating reports.
- Conducted in-depth data analysis and prepared actionable reports and dashboards using tools like Excel/SQL.
- Created comprehensive project documentation including business requirements, process flows, and user guides.
- Collaborated with cross-functional teams to streamline workflows and enhance project efficiency.
- India
Education
Masters of Science (M.S) - Health Informatics
Governors State University
05.2023
Bachelor Of Science (B.S) - Biotechnology
Osmania University
06.2016
Skills
- Regulatory compliance (FDA, GCP, ICH, HIPAA, IND)
- Subject screening
- Recruitment
- Informed consent
- Electronic Data Capture systems
- Microsoft Office Suite (Excel, Word, PowerPoint)
- Analytical & Problem-solving skills
Timeline
Clinical Research Coordinator
BridgeBio
09.2023 - Current
Associate Consultant
Flairbee Corporation
09.2016 - 03.2021
Masters of Science (M.S) - Health Informatics
Governors State University
Bachelor Of Science (B.S) - Biotechnology
Osmania University
Similar Profiles
Chloe DiezChloe Diez
Therapeutic Sales Specialist: ATTR/Rare Disease at BridgeBioTherapeutic Sales Specialist: ATTR/Rare Disease at BridgeBio
Shylaja SundaresamShylaja Sundaresam
Accounts Payable Specialist (Contract) at BRIDGEBIOAccounts Payable Specialist (Contract) at BRIDGEBIO
Luis Sanchez MolinaLuis Sanchez Molina
Clinical Research Coordinator II/Clinical Research Nurse at Moffitt Cancer CenterClinical Research Coordinator II/Clinical Research Nurse at Moffitt Cancer Center
NADEEM M AKHTARNADEEM M AKHTAR
Clinical Research Coordinator III in Multi-Clinical Trials (NASH) and Cirrhosis [phase 2 and 3 ] at Fresno Clinical Research CenterClinical Research Coordinator III in Multi-Clinical Trials (NASH) and Cirrhosis [phase 2 and 3 ] at Fresno Clinical Research Center
Francesca VerganiFrancesca Vergani
Clinical Project Manager | Clinical Research Coordinator at Fondazione IRCCS Istituto Nazionale dei Tumori di MilanoClinical Project Manager | Clinical Research Coordinator at Fondazione IRCCS Istituto Nazionale dei Tumori di Milano