NADYEH ALMESHNI, MS

ad2kij@r.postjobfree.com 551-***-**** linkedin.com/in/nadyeh-almeshni-561605237

SUMMARY:

A Clinical Research specialist and a Biotechnologist with expertise in various areas such as ICH GCP E6 R2, informed consent, data management, and clinical trial operations. I possess a strong knowledge of research protocols and ensure adherence to guidelines throughout clinical trials. Also have a comprehensive understanding of the informed consent process and prioritize patient safety and ethical conduct. I have a background in molecular and biotechnology laboratories and a proven track record of accurate research while following safety protocols. I`m eager to utilize my science expertise to support and contribute to biotech and clinical research projects.

CLINICAL RESEARCH TRAINING:

Clinical Research Fastrack Dec. 2023 Clinical Research Training covering Core Competencies including:

ICH GCP E6 R (2)

FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46

Data Management

Informed Consent Process

Clinical Trial Operations from feasibility through close-out

GDP following ALCOA-C principles.

Identification and reporting of AEs and SAEs

Quality Assurance, Monitoring and Query Resolution

Comprehension and Execution of Clinical Trial Protocols

Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other Investigator Site File (ISF) documents.

CERTIFICATES & TRAINING:

Good Clinical Practice - ICH E6 (R2) Clinical Research Fastrack - TransCelerate Approved Dec. 2023

Dangerous Goods Training Mayo Clinic Dec. 2023

Certified in Biobank2x: Biospecimen Research methods Feb. 2023

LANGUAGES:

English

Arabic

RELEVANT SKILLS:

GDP

Quality Assurance Audits

Good Clinical Practice (GCP)

Informed Consent

ALCOA-C

Electronic medical records

Adverse event reporting

Clinical practices

Case report forms

Electronic Health Records (HER)

Medical Terminology

Data collection

Microsoft office (Excel, power point & word)

Cell culture

DNA and RNA analysis/extraction

Critical/Analytical thinking

Research

Conflict Resolution

PROFESSIONAL EXPERIENCE:

Research Assistant and Co-author

FDU molecular Biology Lab Teaneck, NJ Jan. 2023 - Jun.2023

Conducted & published research on the effect of hydrocortisone and copper on inflammatory and extracellular matrix remodeling proteins in normal and cancer cells.

Meticulously followed SOPs and protocols to achieve quality results performing cell culture.

Changed cell media per protocol to maximize cell growth and proliferation.

Performed cell counting per SOP.

Utilized good documentation practices similar to ALCOA-C to document data and results.

Utilized source document templates to record cell count information.

Centrifuged samples ensuring that centrifuge was balanced, and optimal settings were utilized to properly separate samples.

Performed multi-step, highly detailed DNA and RNA extraction and analysis.

Microbiologist

American Medical Laboratories Jerusalem Apr. 2014 - Apr. 2020

Prepared laboratory stock standards utilizing primary standards.

Prepared client samples for analysis Compose and send client reports.

Maintained QC Provided support to the different departments in the Lab.

Communicated research results to individuals in industry, government, and public.

Collected and analyzed biological data about relationships between organisms and environment.

Extracted DNA and genotype samples using SNP technology.

Executed corrective actions when test controls were outside specified limits.

Handled specimens according to laboratory protocols to maximize accuracy and precision of results.

Lab Technician

Herskovits Lab Tel Aviv Sep.2009 - Nov.2012

Helped scientific and engineering teams improve research and plans by sharing knowledge.

Handled specimens according to laboratory protocols to maximize accuracy and precision of results.

Maintained confidentiality of all patient information to conform to HIPAA, internal and other regulatory standards.

Recorded, analyzed, and interpreted data.

Monitored staff actions and laboratory procedures to uphold compliance and protect integrity of collected research.

Evaluated collected data points from experiments to produce summary reports.

RELATED COURSE WORK:

Good clinical Practice

Transporting Dangerous Goods

Genetics

Cellular Biology

Chemistry Biochemistry and Advanced Biochemistry

Bioinformatics

Bioethics of molecular Biotechnology

Human Physiology

Molecular endocrinology

EDUCATION:

Master of Science in Biotechnology Concentration GPA: 3.8/4 Fairleigh Dickinson University

Bachelor of Science in Biology -Biochemistry GPA:3.7/4 Bir -Zeit University

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