Nourehan Assem, MSc.
Clinical Project Lead at MARC- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
English Full professional proficiency
-
Arabic Native or bilingual proficiency
Topline Score
Bio
Credentials
-
Interpersonal communication
LinkedInNov, 2022- Nov, 2024 -
Project management foundations
LinkedInOct, 2022- Nov, 2024 -
Group A1: GCP for Basic Biomedical Research
CITI Program, A Division of BRANYMar, 2021- Nov, 2024 -
Group A2: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus).
CITI Program, A Division of BRANYMar, 2021- Nov, 2024 -
Group C - GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
CITI Program, A Division of BRANYOct, 2018- Nov, 2024 -
Clinical Research Coordinator (CRC)
CITI Program, A Division of BRANYApr, 2016- Nov, 2024
Experience
-
MARC
-
Egypt
-
Research Services
-
1 - 100 Employee
-
Clinical Project Lead
-
Jul 2022 - Present
-
-
-
ClinMax CRO
-
Egypt
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Associate Clinical Project Lead
-
Aug 2021 - Jun 2022
-
-
-
Weill Cornell Medicine - Qatar
-
Qatar
-
Higher Education
-
300 - 400 Employee
-
Research specialist
-
Jan 2020 - Jun 2021
-
-
-
Weill Cornell Medicine - Qatar
-
Qatar
-
Higher Education
-
300 - 400 Employee
-
Senior Clinical Research Coordinator
-
Mar 2015 - Nov 2019
● Perform routine monitoring visits according to the monitoring plan to ensure site adherence to protocol and all study guidelines.● Preparation and submission of projects' proposals for grant applications. ● Organizing Ethics committee submissions with follow through to ensure successful outcome.● Performs liaison activities with Research Ethics Board, funding agencies, and external researchers’ collaborator.● Educate research team on the protocol requirements, FDA Regulations, GCP and ICH guidelines, reviewing S.O.P’s for site monitoring, informed consent process, study design, protocol preparation, and requirements of Weill Cornell Medicine.● Reviewing S.O.P’s for site monitoring, maintaining trial master file and other various regulatory requirements for clinical trial processes.● Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.● Speaks with patients to explain study details and provides relevant materials and Obtains informed consent and acquires clinical specimens and data as required by the protocol(s). Ensures good Clinical Practices compliance.● Oversees the review and comparison of source documents with electronic input.● Tracks and reports progress of data collection, data entry, and data cleaning to the Principal Investigator. Maintains and protects confidential research data. ● Lead and monitor the transcription of clinical data form EMR (Cerner) to CRF.● Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database (RedCap). Ensure that queries generated during cleaning are responded to in a timely fashion.● Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.● Monitor study progress such as patient recruitment and protocol compliance.
-
-
-
Future University in Egypt
-
Egypt
-
Education Management
-
700 & Above Employee
-
Teaching assistant of clinical pharmacology
-
Oct 2009 - Mar 2015
• Designing practical course material.• Teaching practical course material and developing students' practical skills.• Supervising laboratory preparation during semester.• Constructing, supervising and mark practical exams to the students. • Conducting administrative work includes advising and registration work to students. • Knowledge and ability to conduct scientific literature reviews where applicable.• Understands scientific principles to conduct research procedure in order to operate laboratory instruments and equipment.• Conducts tests, experiments, and/or procedures following standard or detailed protocol.• Identifies problems, troubleshoots and analyzes variations observed and reported in regular testing protocols.
-
-
-
GSK
-
United Kingdom
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
medical representative CNS line
-
Sep 2008 - Sep 2009
• Arranging meeting with physicians and pharmacists to promote the company's products. • Getting feedback from physicians and pharmacists concerning patient's compliance from using company's products. • Planning work schedules, weekly and monthly timetable.• Monitor competitor activity and competitors' products. • Monitor sales targets during the year and reaching annual sales targets. • Arranging meeting with physicians and pharmacists to promote the company's products. • Getting feedback from physicians and pharmacists concerning patient's compliance from using company's products. • Planning work schedules, weekly and monthly timetable.• Monitor competitor activity and competitors' products. • Monitor sales targets during the year and reaching annual sales targets.
-
-
Education
-
Ain Shams University
Bachelor's Degree, Pharmaceutical Sciences -
Al-Azhar University
Master’s Degree, Pharmacology -
Notre Dame Des Apotre
High School