Mamdouh Beshara

Experience

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  Private Practice

  Mar 1985 - May 2000

  MD
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  Medco Pharmacy

  Jun 2000 - May 2013

  Pharmacy Technician
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  The Ohio State University Wexner Medical Center

  May 2013 - May 2019

  Worked in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. Performed day to day activities related to clinical research studies including recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting and complete case report forms. Independently, consistently, and accurately demonstrated skills and abilities resulting in high quality work. Managed broad range of different type of clinical studies, navigates available resources appropriately, effectively used all available tools. Performed activities independently with quality checks of the work. Served as a leader of multidisciplinary teams establishing and maintaining communications with Investigator, research team, sponsor, and other applicable individuals/groups. Show less I was responsible for the coordination and oversight of clinical research protocols investigating thyroid and neuroendocrine malignancies. Coordinated clinical research activities to include identifying and assessing eligibility of patients for clinical research study participation; discussing research studies with patients and their family members; obtains informed consent and assists with IRB submissions, modifications, and amendments. Ensure that all necessary data is collected and reported as appropriate; provides support to the members of the clinical research team in developing plans to meet the requirements of new clinical research studies. Developed and created detailed reports and presentations in response to data and reporting requests; participated in internal and external quality reviews; analyzes, queries, interprets and summarizes data; collects and extracts data; ensures and verifies data integrity. Show less

  • Senior Clinical Research Coordinator

    Dec 2016 - May 2019

  • Clinical Research Coordinator

    May 2013 - Dec 2016
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  OhioHealth

  May 2019 - now

  Senior Consultant Research QA at OhioHealth

  Activities include a variety of complex and varied support functions including developing and managing the research education program, extensive quality assurance review across multiple complex studies through monitoring and auditing activities, establishing, and implementing process improvement projects and developing and managing a policy, procedure, and guidance program.• Assist with activities within the QA program for monitoring research projects that are not monitored via a Good Clinical Practice compliant monitoring plan and routinely audit all trials. • Work to establish and implement strategic goals for the quality assurance program. • Develop and maintain a monitoring and audit plan process and associated documents to accurately record findings. • Participate in protocol feasibility based on risk matrix and review of protocols for quality assurance input. • Maintain quality assurance and control metrics to track, trend and create/present reports provided to OHRI leadership. • Perform extensive QA review across multiple complex studies of different therapeutic areas and phases and report findings to management and research team. • Review and monitor the staff’s plan to resolve any action items.• Assist in risk assessments and the preparation of any reports. • Assist and maintain the policy, procedure, and guidance program. • Monitor the compliance of institutional policies and procedures as related to research project quality assurance. • Author and train others on developing, submitting, and updating standard operating procedures, guidance, and templates to ensure quality assurance. • Assist with the development and management of the OHRI education and training program. • Assist with the development and continuous improvement of the education and training program designed to promote adherence to policies and regulations for staff involved in human subject research. Show less