Salma Ahmadzai
Clinical Research Professional
El Dorado Hills,CA
Summary
Clinical research professional with proven experience coordinating and monitoring clinical trials in compliance with FDA and GCP guidelines. Skilled in protocol adherence, regulatory documentation, and maintaining data integrity while prioritizing participant safety. Recognized for collaborative teamwork, adaptability, and strong organizational and analytical skills in fast-paced research environments
Overview
5
5
years of professional experience
2026
2026
years of post-secondary education
5
5
Languages
Work History
CLINICAL RESEARCH ASSOCIATE
Machaon Diagnostics
Berkeley, California
10.2022 - 04.2024
- Maintained thorough documentation for clinical trials, including Trial Master Files (TMF), ensuring adherence to ICH-GCP and FDA regulations
- Responsible for monitoring the progress of clinical studies at investigator sites and ensuring that studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICHGCP, and all applicable regulatory requirements.
- Led the development and oversight of (e)TMF and clinical study binders, streamlining research project data collection and reducing manual workload by 5%.
- Spearheaded the recruitment of clinical study participants and authored Informed Consent forms (ICF) and Clinical Protocols, while ensuring the meticulous maintenance of Case Report Forms (CRF's) in compliance with HIPAA and Good Clinical Practice (GCP) guidelines
- Developed and refined clinical study protocols, ensuring compliance with regulatory guidelines and scientific validity
- Skilled in participant recruitment strategies and obtaining informed consent, upholding ethical standards and participant confidentiality
- Coordinated participant scheduling, follow-up visits, and study calendars in alignment with protocol timelines and institutional requirements
- Interfaced with IRB and institutional departments to submit study documents, amendments, and ensure regulatory compliance across all trial phases
- Experience in adverse event reporting, ensuring timely and accurate communication with regulatory authorities.
- Prepared and participated in internal and external audits, ensuring continuous readiness for regulatory inspections.
QUALITY CONTROL SPECIALIST
Lonza Pharma and Biotech
Hayward, California
01.2022 - 07.2022
- Aliquoting and managing samples, cell banks and documentation for the QC department Creating LIMS template and placing samples in the appropriate storage
- Sending shipments to external customers and testing sites
- Identify training needs and organize training interventions to meet quality standards
- Collaborated with cross-functional teams to resolve any discrepancies or issues related to sample management, documentation, or shipment logistics, ensuring seamless operations within the QC department
- Ensure compliance with national and international standards
- Maintain documentation of quality control activities
- Participated in internal audits and quality assurance activities to uphold compliance with regulatory guidelines and quality management systems.
- Executed precise sample placement within designated storage facilities, adhering to strict protocols to maintain sample integrity and accessibility for testing and analysis.
EKG TECHNICIAN
BioTelemetry
San Francisco, California
05.2019 - 01.2021
- Monitor patients' cardiac performances and alerting nurses or physicians to abnormalities or changes in patient responses
- Conducted real-time monitoring of patients' cardiac performances utilizing advanced EKG monitoring equipment
- Observed and analyzed EKG data, promptly identifying abnormalities or significant changes in patient responses
- Collaborated closely with medical staff, promptly alerting nurses or physicians to critical findings and providing detailed reports for further evaluation and intervention
- Maintained strict adherence to established protocols and procedures to guarantee the highest level of patient care and data integrity
Education
Bachelor of Science - Cell and Molecular Biology
California State University
Hayward, CA06-2025
Skills
- Documentation management
- GCP & FDA Regulatory Compliance
- Informed Consent Process
- Clinical Trial Monitoring
- Trial Master File (TMF/eTMF) Maintenance
- Protocol Development & Implementation
- Data Entry & Quality Assurance
- Team collaboration
- Effective communication
Publications
Rachlin, K., Wahbeh, H., Delorme, A., Radin, D., Carpenter, L., Ahmadzai, S., Valletta, S., Yount, G., Salivary neutrophil sampling feasibility in general population for gene expression analysis., BMC research notes, 15, 1, 256, 2022, https://doi.org/10.1186/s13104-022-06149-2
Timeline
CLINICAL RESEARCH ASSOCIATE
Machaon Diagnostics
10.2022 - 04.2024
QUALITY CONTROL SPECIALIST
Lonza Pharma and Biotech
01.2022 - 07.2022
EKG TECHNICIAN
BioTelemetry
05.2019 - 01.2021
Bachelor of Science - Cell and Molecular Biology
California State University
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