Afreen Ali
North Hollywood,CA
Summary
Results-driven Coordinator with expertise in Clinical Trials project management and team leadership. Streamlined operations and enhanced productivity through effective cross-functional collaboration. Coordinated multiple studies concurrently while meeting critical deadlines, leveraging strong communication and problem-solving skills to drive positive outcomes.
Overview
3
3
Languages
5
5
years of professional experience
Work History
Regulatory Ops Coordinator
IQVIA Laboratories
Valencia, CA
09.2024 - Current
- Responsibilities are centered around CDx (Companion Diagnostics) and IVD (In Vitro Diagnostics) studies.
- Lead study coordinator on 10+ Anatomic Pathology studies.
- Lead study coordinator on multiple Automated Chemistry IVD studies.
- Studies include NSCLC (Non Small Cell Lung Cancer), Breast Cancer, TNBC (Triple Negative Breast Cancer), Urothelial Carcinoma, HNSSC (Head and Neck Squamous Cell Carcinoma), and Ovarian Cancer.
- Primary focus on PD-L1 22C3 stains but familiar with PD-L1 SP263, Nectin-4, HER2, ER, PR, and Claudin.
- Primary focus on PRO-C3, pTau181, pTau217, NFL, S100, NSE, IL6, and GFAP.
- Clinical trials from Phase I - III.
- ER (External Reproducibility), RR (Reference Range) establishment, Reproducibility, and MCE (Multi-Center Evaluations).
- Conducted comprehensive on-site and remote monitoring visits, including Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) to ensure trial integrity and compliance.
- Acquired site-level Institutional Review Board (IRB) approval for all studies.
- Supported internal and external stakeholders to execute site qualification, study setup, and site initiation as detailed in protocol documentation.
- Managed, reviewed, and maintained key trial documentation for accuracy in Trial Master File (TMF) and Investigator Site File (ISF) in alignment with Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines.
- Responsible for resolving or facilitating resolution of data discrepancies found during sponsor visits.
- Documented deviations in compliance with study protocol and participated in investigation and resolution.
- Ensures effective communication between the sponsor and lab operations related to study.
- Attends study calls to stay abreast of study needs and ensures follow up on assigned actions.
- Ensures adequate inventory of reagents for training and sample analysis.
- Partners with management to ensure training records, competencies, and documentation for lab staff dedicated to the study are up to date.
- Partner with lab management to ensure sample analysis in accordance with study timelines.
Medical Lab Assistant I
IQVIA Laboratories
Valencia, CA
01.2024 - 08.2024
- First-hand experience working with Pathologists to best assist and organize samples and study criteria
- Performed and documented analytical procedures according to company procedures and regulatory guidelines.
- Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
- Enters data analysis results for upload to LIMS system under the guidance of senior-level staff.
- Assisted in troubleshooting and process improvements to enhance data quality and streamline turnaround times, including updating standard procedures.
- Worked alongside Study Coordinators for Pathological Complete Response (PCR) studies
- Acts as a technical resource for laboratory staff and supports the team in the absence of the line manager.
- Facilitates post-analysis storage and sample banking.
- Communicated clearly and promptly with cross-functional stakeholders to ensure alignment and efficiency.
- Provided administrative and technical support to optimize laboratory operations.
- Participates in continuing education through self-study, attending training sessions and lectures and meetings.
- Support safety, quality, and 6S requirements and initiatives.
- Compliance with company's procedures and applicable regulatory requirements.
Program Assistant (STDT 2)
UC Davis Human Ecology Lab
Davis, CA
09.2021 - 12.2021
- Adhere to childcare licensing requirements for health and safety.
- Maintain an organized classroom environment
- Sanitized and disinfected educational materials and surfaces according to NAEYC frequency standards to maintain a safe learning environment.
- Utilized child-safe cleaning products to promote safety and health in classroom settings.
- Diluted chemical products to prepare stock solutions in preparation for the workweek.
- Maintained inventory of cleaning agents to ensure availability and compliance with safety standards.
Education
Bachelor of Science - Genetics and Genomics
University of California Davis
Davis, CA03-2023
Skills
- IRB collaboration
- Clinical trial oversight
- IVD coordination
- Regulatory adherence
- Protocol compliance
- Data quality management
- Documentation management
- LIMS utilization
- Experience with eTMF (ie Veeva, Box, and SharePoint)
- Budget management
- Process optimization
- Project timeline management
- Microsoft Office proficiency
- Adaptability
- Attention to detail
- Effective communication
- Team collaboration
Accomplishments
- Recipient of the Benjamin A. Gilman International Scholarship (Fall 2022)
- This scholarship is a nationally competitive scholarship that focuses on student diversity in study abroad programs, funded by the Bureau of Educational and Cultural Affairs at the U.S. Department of State. This merit scholarship is awarded to students with the goal of emphasizing multicultural diversity and integration.
Languages
English
Native/ Bilingual
Bengali
Native/ Bilingual
Hindi
Native/ Bilingual
Timeline
Regulatory Ops Coordinator
IQVIA Laboratories
09.2024 - Current
Medical Lab Assistant I
IQVIA Laboratories
01.2024 - 08.2024
Program Assistant (STDT 2)
UC Davis Human Ecology Lab
09.2021 - 12.2021
Bachelor of Science - Genetics and Genomics
University of California Davis