Project Manager Clinical Research
Resume:
Hanan Abdel-Monem
Cell Phone: +2-010********
***************@*****.***
Citizenships: United States of America, Canada, and Egypt
OBJECTIVE
Accomplished, achievement-driven and results-oriented professional interested in working as a Clinical Research leader for a well established organization.
EDUCATION
Master of Science – Renal Pathology October 1999
University of Alberta-Edmonton
Alberta, Canada
Bachelor of Medicine; Bachelor of Surgery December 1990
Cairo University
Cairo, Egypt
Bachelor of Science – Human Anatomy & Physiology September 1986
Cairo University
Cairo, Egypt
Examinations
ECFMG Certificate January 2005
Related courses
• Immunology courses
Graduate School of Biomedical Science,
University of Texas, Houston, Texas, USA
September, 1996 – December, 1996
• Stereological methods
Banff conference, Alberta, Canada
September, I994
WORK EXPERIENCE
Ray –CRO Cairo -Egypt
Clinical Project leader- 2011 – Present
• Manage interdisciplinary clinical research projects, as Project Manager, leading the clinical team to ensure on-time, on- budget performance
• Supervise, train, and mentor Clinical Research staff.
• Approve investigator study budgets and contracts
• Review and approve regulatory and administrative documents from investigator sites
• Supervise protocol development, operational manual development and the assimilation of all resources and services necessary to perform contracted services
• Review and approve Case Report Forms (CRFs)
• Plan, coordinates, and present at Investigators, Meetings
• Participate in proposal meetings with potential clients
• Review Serious Adverse Event (SAE) reports.
• Author Clinical Study Reports
• Train CRAs on monitoring, internal procedures, and query resolution
• Mentor Senior CRAs on project management procedures and policies
• Provide direct communication link between Company and Sponsor to assure that the needs of the project are met, reporting all areas of concern to assure timely and appropriate resolution of client issues.
• Assure all aspects of clinical trial operation and reporting are performed in accordance with client requirements, applicable corporate SOPS, ICH and GCP guidelines
Baylor College of Medicine – Houston, TX 2005 – 2011
Clinical Research Co- investigator - Cardiology Study 2009 – 2011
• Facilitate and coordinate multi departmental research projects, both inpatient and outpatient
• Enrolled 150 patients in first 15 months of study
• Conduct patient consent, patient screening and tests, interim visit and study close outs
o Accessed patients medical records
o Facilitated monitoring visits
• Ensure completeness of source documents and Case Report Forms (CRFs); entered data into EDC system
• Established study regulatory documents and maintained complete and accurate records of adverse events reports, protocol deviations, IRB and other regulatory documents; managed and maintained site Master Files (SMF)
• Perform literature searches by using library online database and wrote research articles
• Wrote manuscripts for preparation of grant proposals
• Ensured of collection of medical and lab data and processed samples
• Trained and supervised clinical research coordinators and research assistants on protocols, ICH and GCP guidelines
• Well knowledge of FDA regulations
• Highly efficient Computer skills (MS office, MS Excel, and MS power point)
• Highly efficient Internet skills
• Strong organizational time and management skills
Post-Doctoral Fellowship – Pathology Department 2007 – 2009
• Study the effect of phostidylserine binding opsnions on the clearance of micro vesicles and defective in the clearance of micro vesicles lead to hyper coagulable
• Investigate of the role B2- Glycoprotein in the clearance of micro vesicles and their association with antiphospholipid antibodies
• Utilize in vitro coagulation assays, in vivo animal model and various lab techniques such as Elisa, western blot, flow cytometry
• Perform literature searches by using library online database and wrote research articles
Clinical Research Co- Investigator
Post-Doctoral Fellowship - Phase II-III Pulmonary Study 2005- 2007
• Recruited and enrolled 60 patients in the study within the timeline
• Facilitate and coordinate multi departmental research study, both inpatient and outpatient
• Wrote study protocol and prepared manual for study related test
• Conducted patient consent, patient screening and testing, interim visits and study close outs
• Trained fellows, nurses, and research assistants on GCP and ICH guidelines
• Performed Spirometry on patients
Primary Care Clinic – Cairo, Egypt 2001 -2005
Family Practitioner
• Examined patients at a primary care clinic
MEMBERSHIPS & HONORS
Member; International Society of Nephrology
PENDING PUBLICATIONS:
A Pilot Double-Blind, Randomized, Placebo- Controlled Trial of Curcumin / Bioperine for Lung Cancer Chemoprevention in patient with Chronic Obstructive Pulmonary Disease
PUBLICATIONS
Hanan Abdel-Monem; Swapan K.Dasgupta*; Anhquyen Le; Anthony Prakasam; Perumal Thiagarajan; Phagocytosis of platelet microvesicles and B2-glycoprotein I. Blood Coagulation, Fibrinolysis and Cellular Haemostasis. Thromb Haemost. 2010 Jun 10; 104(2). [Epub ahead of print]
Hanan Abdel-Monem, Anthony Prakasam, Perumel Thiagarajan: Howell-Jolly Body-Like Inclusions in Neutrophils of a Transplant Recipient in Association with Ganciclovir Therapy. Archies of Pathology & Laboratory Medicine 2010: Vol. 134, No.6, pp. 809-810.
Dasgupta SK, Argaiz ER, Mercado JE, Maul HO, Garza J, Enriquez AB, Abdel-Monem H,Prakasam A, Andreeff M, Thiagarajan P: Platelet senescence and phosphatidylserine exposure. Transufion. 2010 May 7. [Epub ahead of print]
Abdel-Monem H 1, Dasgupta S1 Niravath P, Le A, Bellera R, Langlois K, Rumbaut R and Thiagarajan P: 1 These two authors contributed equally. Lactadherin and clearance of platelet-derived microvesicles. Blood. 2009 Feb; 113(6); 1332-1339, Cited in PubMed; PMID: Epub 2008 Nov 20.
Dasgupta S, Abdel-Monem H, Guchhait P, Nagata S and Thiagarajan P. Role of lactadherin in the clearance of phospatidylserine-expressing red cells. Transfusion. 2008 Nov; 48(11); 2370-2376. Cited in PubMed; PMID: 2008 Jul 17.
Ivanyi B, Fahmy H, Brown H, Szenohradszky P, Halloran PF, Solez K. Peritubular capillaries in chronic renal allograft rejection; a quantitative ultrastructural study. Human Pathology. 2008 Sep; 31(9): 1129 – 1138.
Solez K, Battaglia D, Fahmy H, Tropkov K. Pathology of Kidney Transplant Rejection. Current Opinion in Nephrology and Hypertension 2:904-911, 1993. 84. 1993 Sep; 84(2): 904-911.
Contact this candidate