1. Emad Ghaly, M.D.
10008 Juniper Trace Dr. Charlotte, NC 28277 * Phone: (201)788-1372 * Email: eghaly1@gmail.com
Summary of Qualifications
Dedicated Healthcare professional with comprehensive training and experience as a health
care provider and clinical research coordinator.
Mastery level of GCP, and ICH Guidelines, FDA Regulations, with strict adherence to SOPs and study protocols.
Comprehensive Knowledge of regulatory documents managements and IRB submissions.
Experienced in managing and coordinating clinical research studies phase II to phase IV starting from pre-site
visit, site initiation visit, to study closure visit.
Demonstrated ability to develop, build, and maintain critical relationships with; Health Care Professionals
(HCPs),Key Opinion Leaders (KOLs),and academic thought leaders.
Ability to learn and incorporate new ideas, concepts, methods, and technologies, with professional response to
fast-paced situations and at ease handling of emerging and changing requirements.
Proficient in the use of a wide variety of computer programs and applications including; Microsoft office, Oracle
RDC ; Medidata Rave,BIRT, InForm, ClinTrak, and Clinphone.
Education, Licensure and Certification
IATA certification 2016
GCP Certification, 2014
Advanced Cardiovascular Life Support [ACLS], instructor, 2012
Advanced Trauma Life Support (ATLS),Instructor, 2011
USMLE Certification, 2011
Basic Life Support for Healthcare Providers [BLS], Instructor, 2010
Master’s Degree of Anesthesiology& Critical Care, University of Zagazig, Egypt.1995
M.B.B.CH. University of Alexandria, Egypt.1991
Employment
07/2014 – Present Burke Internal Medicine& Research,Burke,VA Clinical Research Coordinator
06/2012 – 07/2014 Everest College Tysons Corner, VA Medical Assisting Lead Instructor
05/2011 – 06/2012 Bayonne Pediatrics. Bayonne, NJ Clinical Coordinator& Office Manager
09/2003 – 04/2011 Ministry of Health Hospitals, Kuwait Attending Physician, AL-Jahra Hospital
03/1992 – 08/2003 Ministry of Health Hospitals, Egypt Attending Physician, Abokeer Hospital
2. Emad Ghaly, M.D.
10008 Juniper Trace Dr. Charlotte, NC 28277 * Phone: (201)788-1372 * Email: eghaly1@gmail.com
Research Experience
For more than two years working as Clinical Research Coordinator at Burke Internal Medicine and Research; support,
facilitate and coordinate the daily clinical trial activities and play a critical role in the implementation of protocols. Work
with the PI and sponsor to support and provide guidance on administration of compliance, financial, personnel and other
related aspects of the clinical study.
Data entry and query resolution matrix of research site have been improved from below 80% to nearly 100%.
Increased subject retention percentage,and achieved up to120% of the recruitment target in some studies.
Primary duties include:
Work as primary coordinator for studies in a wide variety of therapeutics, currently coordinating 8 clinical
studies.
Ensure the implementation of study protocols in accordance with FDA and GCP guidelines.
Supervise research assistants,3 assistants in average.
Therapeutic areas covered include but not limited to; Hypertension, Diabetes, Hematology, coronary artery
disease, Gout, Hypercholesterolemia, Obesity, Hypertriglyceridemia, Arthritis, and Bronchial Asthma.
Selection, recruitment, and retention of subjects for studies participation.
Administrating the Informed Consent Form completion process.
Collecting medical history, AEs, and concomitant medications and documenting this data.
Submitting regulatory documents, AEs,SAEs, and protocol deviations to IRB and Sponsor.
Preparing for study initiation, and do all procedures related to it. Already have Initiated 8 studies.
Teaching subjects about protocol expectations.
Maintaining study files, and regulatory documents.
Collection, packing, and shipping of laboratory specimens.
Attending study-related meetings, conferences,teleconferences,as well as participating in any additional
planning- and development-related activities, as needed.
Data entry and query resolution in various EDC platforms including but not limited to; Medidata Rave,BIRT,
InForm, and Clin Trak.
Communicating with research agents,study sponsor, study vendors, and other patient service providers.