Clinical Research Project Coordinator and Regulatory Expert

Saira Jahangir

*-********@************.***

linkedin.com/in/saira-jahangir-16b730137

Professional Summary

Dedicated and results-driven Research Project Coordinator with over 12 years of experience in clinical research management, regulatory compliance, and biomedical/social- behavioral study coordination. Adept at leading multidisciplinary teams, managing multi- site operations, and ensuring alignment with GCP, FDA, ICH, and IRB requirements. Proven track record of delivering high-quality data, optimizing protocols, and enhancing regulatory workflows. Holds an MD, a Master's in Regulatory Compliance, and a Certificate in Data Science from Northwestern University.

Professional Experience

Northwestern University, Feinberg School of Medicine - Radiology Research Project Coordinator, Nov 2024 - Present

- Leads daily operations of biomedical and social-behavioral research studies involving multidisciplinary teams and external sponsors.

- Oversees and implements new protocols, tracks performance metrics, and ensures protocol adherence across sites.

- Mentors junior coordinators and study staff, fostering team education and protocol compliance.

- Coordinates data collection, medical chart abstraction, eligibility screening, and informed consent processes.

- Develops and administers project budgets, manages procurement, and ensures compliance with grant and administrative guidelines.

- Supports study preparation for publications and presentations; contributes to scientific writing and progress reports.

- Acts as liaison between study teams, sponsors, and collaborating institutions, ensuring efficient communication and regulatory coordination.

- Maintains alignment with federal regulations and institutional policies, including GCP, FDA CFR, ICH, and Northwestern IRB guidelines.

Regulatory Affairs Coordinator, Mar 2023 - Nov 2024

- Managed regulatory compliance for over 100 clinical studies, overseeing IRB submissions, renewals, and amendments.

- Served as IRB Panelist (Panel B), reviewing study protocols and participating in Huron Click IRB quorum management.

- Designed SOPs and workflows enhancing adherence to AAHRPP standards, improving protocol turnaround time.

- Led communication across stakeholders to ensure 95% compliance with sponsor and institutional timelines.

Senior Research Study Coordinator, Aug 2022 - Mar 2023

- Spearheaded recruitment and screening for a multi-site cardiovascular MRI study with 292+ participants.

- Mentored junior team members in research documentation, participant communication, and IRB policies.

- Developed project timelines and executed data quality assurance procedures. Research Study Coordinator, Mar 2021 - Aug 2022

Northwestern University, IPHAM

- Coordinated culturally tailored public health research in South Asian populations, achieving high recruitment and retention.

- Supported study operations across multiple university campuses and co-investigators. Research Consultant / Data Assistant, Mar 2013 - Mar 2021 Northwestern University, Infectious Disease Division

- Managed clinical data abstraction, SOP creation, and interdepartmental communication across HIV/AIDS studies.

Clinical Data Manager, Jun 2011 - Dec 2012

Robert H. Lurie Comprehensive Cancer Center

- Oversaw data abstraction and entry for cancer studies using Epic/Cerner, while developing CRFs and supporting grant reporting.

Education

- Master of Science in Regulatory Compliance, Northwestern University

- Certificate in Data Science, Northwestern University

- Bachelor of Medicine, Bachelor of Surgery (MBBS), Dow University of Health Sciences, Pakistan

Skills

- Project & Budget Management

- Regulatory Compliance (GCP, FDA, IRB, ICH)

- Protocol Development & IRB Submissions

- Multi-site Clinical Study Coordination

- SOP Development & Workflow Optimization

- Data Collection, Analysis & Quality Assurance

- REDCap, SPSS, STATA, R, Qualtrics

- EHR Systems: Epic, Cerner

- Staff Supervision & Training

Certifications & Training

- CITI: Good Clinical Practice, Human Subjects Research, RCR

- HIPAA, Privacy & Security Training

- DTTAC Virtual Lifestyle Coach (Emory)

- NUCATS: EKG, Spirometry, CRC Training, Navigating Research Enterprise Publications

Available upon request or at: linkedin.com/in/saira-jahangir-16b730137

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