Humera Siddiqui
Tomball,TX
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 GCP, BLS and IATA.
Overview
4
4
years of professional experience
Work History
Lead Clinical Research Coordinator III
DM Clinical Research
05.2021 - Current
- Managed data entry and query resolution in Electronic Data Capture and oversaw eDiary processes for regulatory and protocol adherence.
- Proactively recruited and randomized participants for delegated studies, particularly the RSV trial phase II, achieving top enrollment nationwide in the US
- Improved site visit preparation efficiency by assisting CRAs with QC checks, accurate inventory of investigational products, and timely resolution of action items from prior visits
- Streamlined management of clinical trial supplies, enhancing collaboration with the study team, monitors, and sponsors to ensure uninterrupted recruitment and study progress
- Enhanced document access and organization by introducing a standardized file naming system, significantly reducing search times and boosting productivity
- Contributed to the development of SOPs and guidance documents, enhancing operational efficiency and standardizing processes organization-wide
- Implemented an efficient system for compiling and organizing study files using binders, Google Drive, and Florence
- Conducted thorough QC reviews of regulatory and blinded binders, ensuring timely resolution of discrepancies and compliance with established guidelines
- Optimized clinical trial management by ensuring strict adherence to study protocols, ICH-GCP guidelines, and FDA regulations
- Acted as the primary liaison to monitors, streamlining study initiation, interim, and closeout visits for the blinded team
- Maintained comprehensive knowledge of current study protocols, informed consents, study manuals, and all relevant study-related documents, ensuring up-to-date and efficient study management.
Research Data Coordinator
DM Clinical Research
02.2021 - 05.2021
- Managed data entry and query resolution in Electronic Data Capture.
- Oversaw eDiary processes for regulatory and protocol adherence.
- Developed monitoring strategies, conducted audits, and ensured data integrity and participant compliance.
- Created participant engagement strategies to maintain 95%+ eDiary compliance.
- Collaborated with cross-functional teams, reported compliance metrics, and implemented corrective actions.
- Applied project protocol to daily tasks and guided others in its application.
- Acted as a liaison to Project Lead and clients, communicating on all data management (DM) activities.
- Maintained DM project documentation, reviewed deliverables, and delivered study-specific training.
- Produced project status reports, monitored study metrics, and assisted in business development activities.
- Forecasted project hours, identified resource needs, and flagged out-of-scope activities.
- Mentored junior staff and assisted with the administrative and financial management of projects.
Education
Bachelors of Science - Interdisciplinary Studies
University of Houston
Houston, TX05.2018
Associate of Science - Science
Ohio University
Lancaster, OH05.2014
Skills
- ICH-GCP and IATA certified
- Skilled in Microsoft Office 365
- ETMF (Florence)
- Training portal (longboat, firecrest, LMS)
- IWRS/IRT-Endpoint
- EDC (Medidata Rave)
- Patient Cloud, IQVIA
- Clario, Medspace, Preclarus
- BLS Certified
- OSHA
- GCP Certified
- ALCOA
Timeline
Lead Clinical Research Coordinator III
DM Clinical Research
05.2021 - Current
Research Data Coordinator
DM Clinical Research
02.2021 - 05.2021
Bachelors of Science - Interdisciplinary Studies
University of Houston
Associate of Science - Science
Ohio University
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