
Sadaf Sachwani
Clinical Research Assistant

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About me
Clinical Research Coordinator |Medical Doctor | EDC Accuracy | Source Data Accuracy | GCP Certified | Subject Recruitment and Screening
Education

Clinical Research Fastrack
2020 - 2020Diploma Clinical Research Coordinator1. ICH GCP E6 R22. FDA Regulations 21 CFR Parts 11, 50, 54, 563. Data Management Systems, Electronic Data Capture (EDC) systems like MedRio, Medidata, InForm4. Informed Consent Process5. Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties)6. GDP following ALCOA-C principles7. Identification and reporting of AEs and SAEs8. Quality Assurance, Monitoring and Query Resolution9. Comprehension and Execution of… Show more 1. ICH GCP E6 R22. FDA Regulations 21 CFR Parts 11, 50, 54, 563. Data Management Systems, Electronic Data Capture (EDC) systems like MedRio, Medidata, InForm4. Informed Consent Process5. Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties)6. GDP following ALCOA-C principles7. Identification and reporting of AEs and SAEs8. Quality Assurance, Monitoring and Query Resolution9. Comprehension and Execution of Clinical Trial Protocols10. Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF) documents Show less

Sir Syed Medical College
2009 - 2015Bachelor of Medicine, Bachelor of Surgery - MBBS Medicine
Experience
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The Aga Khan University Hospital (Pakistan)
Mar 2013 - Mar 2013Clinical Research Assistant
CVS Pharmacy
Jan 2016 - Aug 2016Pharmacy Technician*Calculated dosages carefully and prepared prescription labels, promoting accuracy in medication administration.*Inspected medication storage locations to monitor drug expiration dates and supply adequate inventory.*Verified labeled prescriptions using 8-point check system to maintain accuracy and efficiency.*Entered orders into system and filled medication orders.*Resolved third-party rejection claims.

Journal Of Palliative Medicine
Jan 2019 - Dec 2019Clinical Research Associate*Outlined key research in documents, spreadsheets and reports.*Edited data collection forms and created questionnaires.*Prepared summaries of research findings and effectively presented them to supervisors.*Checked incoming data for accuracy and integrity to identify and resolve problems.*Supported project leads in preparing regulatory documentation and presentations highlighting findings

Sam's Club
Jan 2020 - Sept 2020OpticianSold and recommended Eyewear products, merchandise and services in retail and clinical settings in order todrive company revenue and meet customer needs.Collected customer measurements such as bridge, eye size, temple length, seg heights, vertex distance, pupillarydistance and pantoscopic tilt.Pulled patient insurance information, placed corrective lenses orders and checked patients in and out ofappointments.

Clinical Research Fastrack
Sept 2020 - Dec 2020Clinical Research Coordinator• ICH-GCP E6 R(2)• FDA Regulations 21CFR 11,50,54,56 & The Common Rule 45CFR46• Data Management• Informed Consent Process• Clinical Trials Operations from feasibility through close-out.• GDP following ALCOA-C• Identification and reporting of AES and SAEs• Quality Assurance, Monitoring and Query Resolution• Comprehension and Execution of Clinical Trial Protocols• Maintaining Regulatory Binder, housing essential documents, including but not limited to FDA 1572, DOA, Training Logs and other Investigator Site Files (ICF) documents• Introduction to the financial aspects of running a clinical trial Show less

Southwest Family Medicine Associates
Mar 2021 - nowClinical Research Coordinator
Licenses & Certifications

Oral Deaf Master Trainer Distance Learning Program on Hearing Impairment
Completion of the prescribed course of Oral Deaf Master Trainer Distance Learning Program on Hearing Impairment.Apr 2010
Basic Life Support for Healthcare Providers (BLS)
American Heart AssociationSept 2021- View certificate

GCP Course that Expires in 2 Years
CITI Program, A Division of BRANYOct 2020
Volunteer Experience
Volunteer
Issued by Baylor Scott & White Health on Jan 2019
Associated with Sadaf SachwaniFundraiser
Issued by Children's Cancer Hospital Foundation on Aug 2015
Associated with Sadaf SachwaniMedical Assistant
Issued by Foundation for a Drug-Free Worldd on May 2010
Associated with Sadaf Sachwani
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