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Research Management Resume Houston, TX
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Title Research Management
Target Location US-TX-Houston
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Candidate's Name , MBBch, MSc.
EMAIL AVAILABLE PHONE NUMBER AVAILABLE
An American citizen with 15+ years of experience in human subject research and pharmacovigilance. EXPERIENCE SUMMARY
Clinical Trials Project Management
Oversaw the design and implementation of a Human Research Protection Program for accreditation by US-based non-profit organization AAHRPP over a 3-year period (2011-2014)
Managed the design and implementation of an IRB review system for research proposals submitted to the Ministry of Health, Saudi Arabia
Created systems for clinical trial teams to manage day-to-day operations
Assisted in creating a research quality improvement plan, tracked key performance indicators,, identified educational and developmental needs in conducting research
Planned and organized interdepartmental an Annual Research Education Week Conference
Collaborated with Roswell Park Cancer Institute to develop a project proposal for establishing research infrastructure at KFSHD
Provided hospital-wide presentations to train and update staff on research systems and regulations
Negotiated clinical trial agreements between pharmaceutical companies and King Khalid Medical City-Center for Health Research
Corresponded with international organizations to establish collaboration and networking opportunities
Created forms, worksheets, checklists and templates to facilitate understanding of research regulations.
Pharmacovigilance
Review of relevant literature for safety information pertinent to evaluation of potential safety signals.
Mentored and trained staff on all aspects of Pharmacovigilance and ARISg database functionality.
Worked on post-marketing recall of Digitek (digoxin) including preparation and review of the FDA form 3500A.
Collaborate with sponsors and internal departments on the review of study-related documents, preparation of PowerPoint presentations.
Generation of descriptive summaries from concomitant medications, laboratory/diagnostic reports, medical notes and discharge reports for incorporation into the MedWatch/CIOMS forms.
Periodic reconciliation between the safety drug database line listings and data management database.
Management Skills
Directed clinical trial teams to successfully screen and recruit patients into over 30 clinical trials
Supervised day-to-day operations of IRB staff
Created over 25 departmental procedures and policies for IRB operations and clinical trial management.
EDUCATIONAL BACKGROUND
Knowledge Systems Institute May 2012 / Illinois, USA Master of Science in Computer & Information Sciences (Health Informatics) Cairo University Faculty of Medicine Aug 1988   Nov 1996 / Cairo, Egypt MBBch
Candidate's Name , MBBch, MSc.
EMAIL AVAILABLE PHONE NUMBER AVAILABLE
EMPLOYMENT HISTORY
Research Executive Administration   KKMC Jan 2010   Nov 2016 / Dammam, KSA Chairman of Human Research Protection Department and prior IRB Member Omnicare Clinical Research July 2007   December 2009 / Pennsylvania, USA Pharmacovigilance and Safety Surveillance Officer Merck & Co., Inc. June 2006   July 2007 / Pennsylvania, USA Clinical Trials Manager
Hinsdale Hospital October 2004   June 2006 / Illinois, USA Physician Assistant

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