NINO KURIAN ZACHARIAH
Brighton,MA
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in Good Clinical Practices, HIPAA, Human subject research, Standard Operating Procedure (SOP) Fundamentals.
Overview
5
5
years of professional experience
Work History
Clinical Research Coordinator
Boston University Medical Center- CTSI
07.2022 - Current
- Conducted thorough study protocol reviews, facilitating seamless site initiation and close-out processes for multiple clinical trials.
- Developed and implemented standardized SOPs tailored to diverse workflows within 4 clusters of department, optimizing efficiency, and ensuring consistency in clinical trial operations
- Spearheaded management and organization of essential study documents, including protocols, CRFs, and NTFs, contributing significantly to improved compliance and audit readiness.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Facilitated Electronic Data Capture (EDC) and robust data management practices per Good Documentation Practices (GDP)
- Conducted comprehensive Quality assurance and Quality control internal audits, meticulously preparing detailed reports for annual compliance checks, ensuring adherence to stringent industry standards and regulations.
Clinical Research Coordinator
Population Health Research Institute- JSS Hospital
07.2019 - 07.2020
- Coordinated and managed submission of ethics committee and regulatory agency submissions, ensuring all documentation was completed accurately
- Gathered, processed, and shipped lab specimens.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Conducted comprehensive root cause analyses of adverse events, collaborating with cross-functional teams to identify contributing factors and implementing preventive measures, resulting in 30% decrease in occurrence rate.
Clinical Pharmacist
JSS Hospital
06.2019 - 06.2020
- Executed comprehensive patient treatment chart review, identified inefficiencies, implemented quality improvement initiatives, reduced medication errors, and improved patient outcomes
- Formulated and implemented comprehensive Poison protocols for poison emergencies to clinical team, cut-rate emergency response time by 50%, and increased patient survival rates by 30%.
Education
Master of Science - Drug Regulatory Affairs
Northeastern University
Boston, MA05.2023
Doctor of Pharmacy (PharmD) -
JSS University
Mysore, India 06.2020
Skills
- Software: REDCap, WebCAMP, EPIC, Qualtrics, eSCODAT, INSPIR, Veeva, Sharepoint, Adobe, BOX, MS Office
- Certification: Good Clinical Practices, HIPAA, Human subject research, Standard Operating Procedure (SOP) Fundamentals, Data Analysis (Basic)
- Soft skills: Leadership, Communication both verbal and written, Problem Solving, Teamwork, Detail Oriented,Clinical Research Ethics,Quality Assurance, Organization and Time Management, Report Preparation
Timeline
Clinical Research Coordinator
Boston University Medical Center- CTSI
07.2022 - Current
Clinical Research Coordinator
Population Health Research Institute- JSS Hospital
07.2019 - 07.2020
Clinical Pharmacist
JSS Hospital
06.2019 - 06.2020
Master of Science - Drug Regulatory Affairs
Northeastern University
Doctor of Pharmacy (PharmD) -
JSS University
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