Haifa Mshaiel
Berkeley
Summary
Detail-oriented clinical research professional specializing in site management and regulatory compliance. Enhanced enrollment and minimized data discrepancies through effective monitoring and CAPA tracking. Expertise in risk-based monitoring and team leadership, driving continuous improvement and ensuring inspection readiness.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Development & Professional Development
Intentional Career Break
08.2022 - 03.2026
- Completed graduate-level oncology, pharmacology, and immunology coursework (CCOM, 2022–2024); coordinated multi-provider care for family medical event, enhancing patient-facing clinical judgment for site conduct and participant retention.
- Ensured smooth operations through meticulous attention to daily responsibilities.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
Senior CRC & Co-Department Lead
Gastroenterology Consultants
Roanoke
01.2022 - 07.2022
- Led site management across 6 concurrent studies as primary sponsor/CRA contact; achieved zero critical findings through continuous inspection readiness, proactive CAPA tracking, and internal monitoring reviews.
- Increased enrollment by 20% through pre-screening workflow improvements; developed 12+ SOPs to standardize site management, monitoring readiness, and protocol compliance, enhancing departmental processes and staff training.
- Enhanced staff performance by mentoring new employees on clinic procedures and protocols.
- Managed patient scheduling to improve physician availability and streamline workflow.
Clinical Research Coordinator II — Oncology
Carilion Clinic
Roanoke
08.2021 - 01.2022
- Oversaw site-level operations for 8 concurrent Phase I–III oncology trials from start-up to close-out; collaborated with CRAs and LTMs during SIVs, IMVs, and close-out visits, ensuring zero critical findings across all sponsor monitoring visits and audits.
- Coordinated communication among PIs, LTMs, sponsors, CROs, IRB, Clinical Operations, and Data Management, facilitating HA/IRB submission and notification processes including protocol amendments and regulatory tracking.
- Reduced data discrepancies by 30% through source-to-EDC reconciliation and timely query resolution; maintained compliance with regulatory and sponsor requirements for AE/SAE/PQC reporting and essential document management.
Clinical Research Coordinator — Oncology
UCSD Moores Cancer Center
La Jolla
01.2020 - 07.2021
- Managed 10+ concurrent Phase I–III oncology trials — including immunotherapy (Cirmtuzumab/anti-ROR1 + paclitaxel), ADC (SYD985/TULIP; Sacituzumab Govitecan HR+/HER2−), and targeted therapy studies — as primary site contact for CRAs and sponsor teams; zero critical findings across all monitoring visits and audits.
- Achieved 15% reduction in avoidable screen failures by enhancing eligibility workflows and escalating investigator concerns before consent; guided 100+ patients through screening, enrollment, and retention in intensive Phase I and Phase III protocols.
- Reduced data discrepancies 25% through source-to-EDC reconciliation, systematic query resolution, and documentation improvements; ensured TMF/ISF essential documents were inspection-ready across all trial phases.
- Implemented risk-based monitoring at site level; identified, documented, and escalated protocol deviations and quality issues within required timelines; tracked corrective and preventive actions to resolution for all audit findings.
- Supported research at NCI-designated cancer center.
Education
Post-Baccalaureate Premedical -
UC San Diego
La Jolla, CA06-2019
BS - Human Biology
UC San Diego
La Jolla, CA12-2017
Some College (No Degree) - Medical Coursework
Chicago College of Osteopathic Medical School
Downers Grove, ILSkills
- Site Initiation (SIV/SQV)
- Clinical Execution
- Monitoring & Site Management
- Risk-Based Monitoring
- Remote Monitoring
- Site Close-Out
- CAPA Tracking
- Regulatory & Compliance
- ICH-GCP
- FDA Regulations
- IRB/IEC Submissions
- Protocol Deviations
- AE/SAE/PQC Reporting
- Eligibility Verification
- Enrollment & Retention
- EDC/Query Resolution
- Medidata Rave
- Veeva Vault
- REDCap
- OnCore
- Advanza CTMS
- Almac IXRS/IRT
- Clario
- EPIC/EMR
- TMF/ISF
- Phase I–III Oncology
- SDV/Source Review
- Clario
- EPIC/EMR
Certification
- CITI Certifications: GCP
- Human Subjects Research
- CRC Training
- HIPAA
- IATA Dangerous Goods
- Clinical Trial Billing
- SOCRA CCRP: In Progress (anticipated within 6 months of hire)
Publications
- PLOS Medicine
- Journal of Clinical Microbiology (2 peer-reviewed; 4 additional supported)
Core Competencies
Site Initiation (SIV/SQV), Risk-Based Monitoring, SDV/Source Review, Remote Monitoring, CAPA Tracking, Site Close-Out, ICH-GCP, FDA Regulations, IRB/IEC Submissions, Protocol Deviations, TMF/ISF, Essential Documents, ClinicalTrials.gov, Phase I–III Oncology, AE/SAE/PQC Reporting, IP Accountability, Eligibility Verification, Enrollment & Retention, EDC/Query Resolution, Medidata Rave, Veeva Vault, REDCap, OnCore, Advanza CTMS, Almac IXRS/IRT, Clario, EPIC/EMR
Timeline
Clinical Development & Professional Development
Intentional Career Break
08.2022 - 03.2026
Senior CRC & Co-Department Lead
Gastroenterology Consultants
01.2022 - 07.2022
Clinical Research Coordinator II — Oncology
Carilion Clinic
08.2021 - 01.2022
Clinical Research Coordinator — Oncology
UCSD Moores Cancer Center
01.2020 - 07.2021
Post-Baccalaureate Premedical -
UC San Diego
BS - Human Biology
UC San Diego
Some College (No Degree) - Medical Coursework
Chicago College of Osteopathic Medical School