EHAB SAKR, MBBCh (MD)

**** ****** **** **** 732-***-****

Bedford, MA 01730 acxoi8@r.postjobfree.com

SUMMARY of Qualifications

Experienced clinical research professional with 10 years of experience in the clinical research field with a strong background in conducting, monitoring and managing clinical trials with implementation of standard clinical research procedures, safety and compliance guidelines. Novel approach real time remote monitoring using Blinded Data Analytics (BDA). Highly proficient in evaluating and interpreting clinical data, articulately presenting complex scientific data to various audiences, and leading cross-functional teams to execute project deliverables.

CORE COMPETENCIES

Clinical Research Monitoring

Implementation of monitoring and recruitment plans. Recruitment and screening healthy controls and patients and scheduling follow-up Manage and order investigational drug supply

Adverse Event Reporting

Ensure adverse events/serious adverse events reported properly; expedited/routine IND safety report & follow-up in timely manner

Scientific Writing

Assist in design of CRF completion

guidelines/protocol review and in preparation of

coordinators manual and source documents

required for conduct of trial

Therapeutic Area

Psychiatry, Neurology, Oncology, Dermatology

Clinical Regulations Compliant

Trained and compliant in FDA clinical research guidelines, GCP & ICH guidelines, ICH GVP, HIPAA & IRB process and regulations

PROFESSIONAL EXPERIENCE

2015-Present Moulder Center for Drug Discovery Research

Temple University School of Pharmacy

Research Scientist, Externship program

Provides high level coordination of the research activities and provide complex technical assistance to principal investigators in support of research activities. This includes design and execution of experimental protocols, collection and interpretation of associated data, reporting of results (internally to colleagues and PI, externally in peer reviewed papers, presentations, and patent applications), and coordination of activities with key program scientists. Participate in laboratory based experiments using electronic and mechanical equipment. Learning about using various separation techniques for isolation and purification of synthesized compounds. Conducting analysis for synthesized compounds

2012 2015 Bracket Global LLC (Wayne, PA), Senior Clinical Scientist-Clinical Development

Worked in Bracket Scientific Services division, providing pharmaceutical and biotech sponsors designs and executes clinical services to enhance clinical trials. Partners with the sponsor clinical representatives to ensure appropriate project definition and clinical deliverables are in accordance with project scope.

Supporting pharmaceuticals companies: Alkermes, Merck, Otsuka, Forrest, Takeda, Shire, Abbive

Consult with trial sponsor to assess objectives and define deliverables, coordinating internally and externally to ensure proper study design

Devise and implement data-surveillance methodologies and regularly reviewed site data to maximize accuracy and validity of study findings

Data extraction/analysis and present data at regular interval

Signal detection (risks and management)

Participate in writing SOP’s and work Instruction groups

Medical review, processing and reporting of ICSRs for project related study

Protocol deviation review/evaluation and provide feedback

Create and monitor quality of project-specific presentations and clinical deliverables, develop protocol-specific CRA training, including clinical content for training and qualification programs, as well as rater training programs for Phase II & III studies

Attend investigators meetings to support trial implementation

Serve as principal point of contact for clinical services and deliverables for multiple, simultaneous global Phase II & III studies

Attend internal and external kick-off meetings and project status meetings throughout the life of a project as required

Develop reporting/analysis plans; coordinate with site staff to resolve data quality issues, compile reports for study sponsors; compose and ensure quality of scientific text

Enhance outcomes at key stages by developing and implementing study-specific rater qualification methodologies; evaluating rater qualification/certification status; and coordinating rater remediation

Designs and ensures appropriate execution of project specific processes and data review methodologies; ensures appropriate training

Ensures development of appropriate clinical content (e.g., qualification methodologies, didactic presentations) for rater training and qualification programs for study staff in clinical trials

Evaluates data submitted in accordance with Endpoint Reliability programs and contacts raters, as appropriate, to gather additional information and provide feedback

Ensures that project clinical deliverables are in compliance with quality control standards

Communicates with study site staff in accordance with project specific methodology/SOPs and documents interaction in the respective IT application

Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines

Participates in business development opportunities as assigned (e.g., client meetings, bid-defenses, preparation of materials)

Developing Leadership Excellence Training – Bracket Global

2010 2011 Pennsylvania State College of Medicine, Pennsylvania Psychiatric Institute

(Harrisburg, PA), Externship Program/Clinical Research

Participated in morning reports, inpatient rotations, grand rounds, etc.

Administered structured clinical interviews for DSM-IV Axis 1 disorders (SCID-l) and clinical ratings

Rotated in the inpatient unit and conducted literature searches for case reports (e.g., Stiff Man Syndrome, Munchausen’s Syndrome)

Assisted in psychiatric evaluations, follow-ups and discharge plans

Presented on mood disorders & suicide

2007 2009 Columbia University Medical Center, New York State Psychiatric Institute

(New York, NY), Clinical Researcher, schizophrenia, psychotic disorders

and substance use disorders

Monitored clinical studies and identified/clarified deficiencies

Developed and maintained SOPs in compliance with the study procedures and best practices

Reviewed informed consent documents/regulatory files

Attended grand rounds, clinical case conferences, lectures

Reviewed the CRF for completion

Ensured documents remained current during the course of trials

Prepared and submitted poster presentations and manuscripts under the guidelines of the Research Steering Committee

Presented research at conferences

2006 2007 Advanced Bio-behavioral Science Research Center (Elmsford, NY),

Clinical Research Coordinator

In partnership with PIs, led end-to-end clinical trial planning, development, management, and evaluation. Designed protocols; participated in recruiting/screening/enrollment of trial subjects; and developed data management processes. Ensured compliance with internal and sponsor organization SOP/policies, IRB requirements, GCP standards, and regulatory agency requirements.

Conducted clinical trials in compliance with protocol, GCP guidelines and FDA regulations

Performed ratings with subjects as per protocol

Development and completion of source documents

PUBLICATIONS

Urban N, Kegeles L, Slifstein M, Xu X, Martinez D, Sakr E, Castillo F, Moadel T, O'Malley SS,Krystal H, Abi-Dargham A. Sex Differences in Striatal Dopamine Release in Young Adults after Oral Alcohol Challenge: PET Imaging Study with [11C] Raclopride. Biol Psychiatry 2010; 68:689-696

POSTERS/ABSTRACTS

Kegeles L, Mao X, Stanford A, Sakr E, Avarez B, Gil R, Abi-Darham A, Sarah H. Frontal Cortex GABA and Glutamate-Glutamine levels in Schizophrenia Measured With Magnetic Resonance Spectroscopy. Presented at the Society of Biological Psychiatry, Vancouver, Canada (May 2009)

Urban N, Xiaoyan Xu, Kegeles L,Slifstein M, Martinez D, Sakr E, O’Malley S,Krystal J, Abi-Dargham A. Imaging Dopamine Transmission with Oral Alcohol challenge: Gender Effects. Presented at the Society of Neuroscience, Chicago, US (October 2009)

EDUCATION

Degree of Medicine and Surgery M.B.B.Ch (MD equivalent). Ain Shams University, Faculty of Medicine, Cairo, Egypt

PROFESSIONAL MEMBERSHIPS

Society of Clinical Research Associate (SOCRA)

APA

TRAINING, CERTIFICATION, & LICENSURE

United States Medical Licensing Exam (USMLE) Step 1, 2 & Clinical Skills Assessment (CSA)

Educational Commission for Foreign Medical Graduates (ECFMG) Certificate, USA

Certificate of Medical Licensure, Egypt

Clinical Research Associate Certificate Program, Fundamentals of Clinical Research, Medical Research Management Inc.

GCP/ICH Certificate, Medical Research Management Inc.

Risk Management and Risk-Based Monitoring

Certified Clinical Research Professional

Certified Phlebotomist; New York State Psychiatric Institute & Columbia University Medical Center

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