WAFA AHMED OMRAN ALSHAMSI
Sharjah
Summary
Detail-oriented Junior Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Junior Clinical Research Associate
IROS CRO
04.2024 - Current
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Identified areas for process improvement within clinical trials, implementing changes to enhance overall project efficiency and quality.
- Collects requested information within required timelines in compliance with all terms of confidentiality and current applicable SOPs.
- Prepares Investigator Site File (ISFs), paper TMFs (Trial Master File) and electronic trial master files (eTMF) for clinical studies, as applicable.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Reviews and reports of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking responsibility for accurate performing of Source Data Verification (SDV), ensures proper transferring of Case Report Forms (CRFs) to Data Management.
Clinical Research Coordinator
G42
04.2022 - 04.2024
- Obtain necessary legal, regulatory, and/or company approvals for conduct of trial.
- Assembles and coordinates distribution of site binders.
- Ensured timely submission of safety reports, supporting overall patient safety throughout trial process.
- Works in collaboration with Principal Investigator (PI) and site staff to coordinate industry sponsored and investigator-initiated clinical trials.
- Collaborate with clinicians to plan and facilitate patient recruitment and retention.
- Coordinate communication with sponsors, partnering departments, vendors, and national agencies.
- Educate study staff on research and trial specifics.
- Manage clinical and administrative study operations to ensure compliance with all IRB (Institutional Review Board), FDA (Food and Drug Administration) and GCP (Good Clinical Practices).
- Adhere to study schedules and timelines.
- Maintain detailed documentation at patient and study level.
- Fulfill reporting requirements in accordance with timelines.
- Provided administrative support such as scheduling meetings, taking minutes, and organizing travel arrangements as needed for project success.
Medical Laboratory Technology Training
Latifa Hospital
05.2021 - 05.2021
- Determined donor eligibility by conducting screenings, interviewing prospective donors and obtaining medical histories.
- Testing blood components for any infectious disease for compatibility.
- Blood storage and handling.
- Sorted and performed quality control measures of donated items.
Medical Laboratory Technology Training
Al Qassimi Hospital
02.2021 - 05.2021
- Labeled blood samples in compliance with regulations and patient identity.
- Reviewed incoming biological samples for correct labeling, registration and patient information.
- Reported results to medical practitioners and other health professionals.
- Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles and straight needles.
- Performed Covid-19 PCR swab tests.
Medical Laboratory Technology Training
Dubai Hospital
01.2021 - 02.2021
- Labeled transfer tubes and followed exact directions for handling and storing specimens for transport.
- Assisted with safe transfusions by conducting tests and completing blood counts.
- Process of separating blood components and store them properly.
- Examined thoroughly cells stained with dye to locate abnormalities.
Medical Laboratory Technology Training
Nadd AlHamar Health Centre
09.2020 - 12.2020
- Followed physician orders when administering therapeutic phlebotomy.
- Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles and straight needles.
- Labeled transfer tubes and followed exact directions for handling and storing specimens for transport.
- Packaged and shipped specimens to central lab daily.
Medical Laboratory Technology Training
Sheikh Khalifa Speciality Hospital
06.2019 - 06.2019
- Disposed of waste correctly, attaching identification tags and arranging collection.
- Logged samples and chemicals to maintain traceability and quality control.
- Prepared clinical samples for biological testing.
- Calibrated laboratory tool and equipment for accurate research outcomes.
Medical Laboratory Technology Training
Rashid Hospital
05.2019 - 06.2019
- Implemented quality control measures to improve validity of findings.
- Performed daily CBC, FBC and ESR tests.
- Increased lab safety by enforcing proper handling, storage, and disposal of hazardous materials.
- Assisted in identification and characterization of microorganisms through advanced microscopic techniques.
Education
Bachelor's degree - Medical Laboraty Technology
Higher Colleges of Technology
Sharjah, UAE06.2021
High School Diploma -
Al Wahda Private School
Sharjah, UAE06.2014
Skills
- Attention to detail
- Site Management
- Detailed documentation
- Electronic Data Capture
- ICH Guidelines
- Informed Consent Process
- Adverse event reporting
- Site monitoring
- Patient recruitment
- Source Document Verification
- Drug Accountability
- NDAs
- Good Clinical Practices
- Research SOPs understanding
Certification
- MOHAP Medical Laboratory Technologist License, NOV 2026
- Good Clinical Practice, APR 2025
- Data Safety and Monitoring Boards for Clinical Trials, NOV 2024
- Introduction to Collecting and Reporting Adverse Events in Clinical Research, NOV 2024
- CRISP Phase 2: Intermediate Knowledge Training Certificate: Mar 2024
- CRISP phase 1: Foundational Knowledge Training Certificate: Jan 2024
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), 2023
- Confidentiality and Data Privacy in Research, 2023
- AHA First Aid CPR AED, NOV 2022
- Monitoring of Clinical Trial Study, SEP 2022
Languages
English
Advanced
C1
Arabic
Bilingual or Proficient (C2)
Clinical Trial Experiences
· Infectious disease: A Randomized, Double-Blind, Positive Controlled, Sequential Study to Evaluate Safety, Immunogenicity, and Cellular Immunity.
· Infectious disease: A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate efficacy, safety, and immunogenicity.
· Infectious disease: A Randomized, Double-Blind, Sequential Study to Evaluate Safety, Immunogenicity, and Cellular.
· Infectious disease: An Observer-Blinded Phase 3 Study to Evaluate Safety and Immunogenicity.
· Infectious disease: A Phase I/III Randomized, Double-blind Study to Evaluate Safety.
Timeline
Junior Clinical Research Associate
IROS CRO
04.2024 - Current
Clinical Research Coordinator
G42
04.2022 - 04.2024
Medical Laboratory Technology Training
Latifa Hospital
05.2021 - 05.2021
Medical Laboratory Technology Training
Al Qassimi Hospital
02.2021 - 05.2021
Medical Laboratory Technology Training
Dubai Hospital
01.2021 - 02.2021
Medical Laboratory Technology Training
Nadd AlHamar Health Centre
09.2020 - 12.2020
Medical Laboratory Technology Training
Sheikh Khalifa Speciality Hospital
06.2019 - 06.2019
Medical Laboratory Technology Training
Rashid Hospital
05.2019 - 06.2019
Bachelor's degree - Medical Laboraty Technology
Higher Colleges of Technology
High School Diploma -
Al Wahda Private School
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