"An organized Clinical Trial Assistant demonstrates a readiness to embrace extra tasks in pursuit of team objectives. Proficient in data collection and review, with a solid understanding of medical terminology."
Overview
13
13
years of professional experience
1
1
year of post-secondary education
3
3
Languages
Work History
Clinical Trial Assistant
DOCS International
05.2020 - 08.2020
Ensure project and study files (Trial Master File (TMF) are set up, maintained and audit ready at all times
Provide administrative support for trials
Redirection SUSAR reports
Assist with management and tracking of study clinical supply.
Internship
Synexus Clinical Research GmbH
10.2019 - 01.2020
Principle of Good Clinical Practice (GCP)
Principle of Good Documentation Practice (GDP)
Principles of monitoring models (risk based, remote, etc..)
Principles about work and tasks of independent ethics committee (IEC) and Regulatory Authority (RA) including submission, queries and approvals
Process of site activation from view of Dedicated Research Site (DRS) Including:
Site Selection
Pre Study Visit
Site Initiation Process
Managing monitoring overview visits (MOV) on Site including preparation as per visit confirmation letter, conduct of MOV and processing action items from monitoring follow-up letter
Data entry of patient note CRFs into EDC systems, worked with these Electronic Data Capturing (EDC) systems:
IBM Clinical Development (former Clinical OS)
Oracle InForm GTM 6.0/6.1
Medidata
Data workflow including data entry, query management, Source Data Verification up to database lock
Regulatory Authority (RA) including submission, queries and approvals
Maintenance of Investigator site file
Archiving process of source data according to GCP.
Clinical Research Associate
mibeg Medicine Institute
04.2019 - 10.2019
Drug Safety and Pharmacovigilance, National and International Basis, Data Management and Evaluation for Pharmaceutical and Medical Products, Clinical Research (Phase1) and Site Visits, Workshop Rheumatoid Arthritis and Digestive system, Basis of Terminology.
Collected, evaluated, and model collected data
Gathered and organised clinical trial documentation to meet rigorous standards for site approval
Chemical Supervisor
Advatec International
09.2008 - 10.2011
Inspector product, analyzed information, identified information By categorizing, monitored products and reviewed detailed information.
Chemistry and Biology Teacher
05.2007 - 07.2008
Able to simply complex chemistry and biology functions in order to provide tutoring for intermediate school students.
Education
Master in Microbiology - Focused in the parasitism and parasitology, immunology. Studied in Cutaneous leishmaniosis in Syria (Aleppo boil) compounded with laboratory work (incomplete). Left Syria without the Master thesis.
Damascus University
Damascus- Syria
10.2012 - 11.2013
Bachelor of Science - Biochemistry. Protein biochemistry: Protein synthesis and controlled protein breakdown, sorting and delivery protein. Genetic engineering: Polymerase chains reaction, electrophoreses, cloning methods, manipulating DNA and genes. Thesis of Staphylococcus aureus. Thesis of Rotavirus. Thesis of Colloidal system.
12/2015 - 08/2016, Linguistic and Cultural Mediation, Düsseldorf, Advised families and refugees in various facilities in Düsseldorf State capital Düsseldorf and by AWO Family Globe GmbH.
12/2015 - 08/2016, Linguistic and Cultural Mediation, Dusseldorf, Advised families and refugees in various facilities in Dusseldorf
09/2015 - 12/2016, Interpreter, Intercultural Medium, Düsseldorf, By Caritasverband Düsseldorf and by state capital Dusseldorf.
Timeline
Clinical Trial Assistant
DOCS International
05.2020 - 08.2020
Internship
Synexus Clinical Research GmbH
10.2019 - 01.2020
Clinical Research Associate
mibeg Medicine Institute
04.2019 - 10.2019
Master in Microbiology - Focused in the parasitism and parasitology, immunology. Studied in Cutaneous leishmaniosis in Syria (Aleppo boil) compounded with laboratory work (incomplete). Left Syria without the Master thesis.
Damascus University
10.2012 - 11.2013
Bachelor of Science - Biochemistry. Protein biochemistry: Protein synthesis and controlled protein breakdown, sorting and delivery protein. Genetic engineering: Polymerase chains reaction, electrophoreses, cloning methods, manipulating DNA and genes. Thesis of Staphylococcus aureus. Thesis of Rotavirus. Thesis of Colloidal system.