Sherif Helmy

Department of Surgery, Transplant Research Center

• Oversight of multi-center NIH funded clinical research ensuring the smooth and efficient operations of research projects activities in compliance with the IRB, HIPAA, and other relevant patient safety and privacy statutes
• Areas of expertise include: OR, Medical devices, Transplant surgery, Oncology, GI Hepatology, Infectious Diseases, HIV, Diabetes, Neurology
• Developed comprehensive project plans, outlining objectives, timelines, budgets, and resource allocation to ensure successful delivery within pre-established scope
• Monitor, and adhere to IRB-approved study protocols, and SOP to internal/external regulatory requirements of NIH, FDA, EMA
• Develop and manage relationships with professional medical leaders and KOLs as well as foster collaborations among internal and external key stakeholders
• Streamline communication between team members for increased efficiency and improved collaboration in achieving project goals
• Evaluate project progress regularly, identifying potential risks and initiating corrective actions to mitigate any negative impact on results.
• Research, collect, and communicate the latest information concerning the latest therapeutic trends impacting patient care and outcomes
• Ensure proper dissemination of quality data and medical information through regular meetings and presentations
• Site lead and Key person in the patient care setting to the physicians and patients
• Assist in developing recruitment tools for assigned studies, which include protocol/study-specific data collection forms and medical data review
• Recruit and coordinate research subjects, including scheduling, conducting study visits, and obtaining informed consent, ensuring timely conduction of study visits and completion of all research aspects
• Act as the primary contact for study participants and administrative point of contact for internal and external research/hospital staff and federal bodies
• Develop and maintain recordkeeping systems and procedures and ensure that source documents, case files, safety documents and accompanying paperwork are organized and current
• Develop complex tracking database/spreadsheet based on study requirements utilizing Microsoft Suite, Google Suite, Share Drive, REDCap, CRMS, IREx, and Epic
• Abstract data EMR and review patient charts that require medical interpretation
• Run pre-established queries and develop ad-hoc queries/reports as requested
• Prepare periodic reports as required by sponsors, investigators and/or regulatory bodies
• Monitor and report any subject adverse events that may occur while conducting study procedures
• Communicate and meet with the Institutional Review Boards for multiple studies to ensure patient safety and compliance with study protocols and regulatory bodies
• Coordinate and participate in meetings to provide operational updates, report on workflow issues, and recommend resolutions to new/tabled operational issues
• Assist with data analysis, interpretation, manuscript, and abstract preparation and review

Transition from clinical practice to clinical research, completed the following courses:

• Clinical Research Methodology
• Biostatistics for Clinical Research
• Medical Ethics and Regulatory Affairs
• Fundamentals in biostatistical analysis and ethical decision-making
• Gained insights into clinical trial design and implementation
• Learned about patient recruitment strategies and ethical considerations
• Developed skills in statistical analysis and interpretation of clinical data
• Learned about data analysis software(s) in research contexts
• Studied ethical guidelines and regulatory policies in clinical research
• Understood the importance of informed consent and patient privacy in research settings
• Acquired knowledge of regulatory standards and compliance requirements in clinical research

End of project evaluation for the health services component of a social services project, which entailed various health, education, and disability services

• Streamlined and conducted meticulous field research and evaluation processes , reducing time spent on administrative tasks and increasing focus on analysis and recommendations.
• Evaluated Medical facility, including medical equipment and supplies and service quality
• Interviewed and surveyed all medical and non-medical staff to collect data and information on the operational processes and compare them to project objectives
• Interviewed and surveyed patients/service recipients to evaluate the quality and availability of services offered to ensure delivery of healthcare services as intended by project objectives
• Developed the final health evaluation report that clearly communicated findings, recommendations, and actionable insights for stakeholders needed to improve service delivery and maintain funding for the project's sustainability

• Served in multiple departments, communicating directly with patients and their families in various clinical settings (outpatient clinics, wards, ER, ICU)
• Performed complete physical examinations, ordered investigations, performed surgical procedures, wrote prescriptions, and confronted various clinical situations varying in nature and complexity
• Participated in quality improvement initiatives to optimize clinical processes and enhance overall patient care standards
• Provided health education to patients and communities on diet, hygiene, disease prevention, and correct misinformation regarding illness and vaccination
• Participated in the national polio vaccination campaign in underserved suburban villages and remote areas in collaboration with UNICEF
• Trained and supervised medical students and subordinate staff in using medical technique, equipment and software.

• Lead the rollout of the new Electronic Medical Records system (EMR), including setup, record transfer, and data entry
• Attended all physician visits to create patient profiles and scribe visit notes
• Reported medical results and provided necessary feedback to physicians and proceeded with physician orders
• Coordinated patient referrals to specialists or other healthcare providers as needed for comprehensive care management plans
• Obtained and Interpreted sleep study results for sleep center patients
• Performed spirometry for intended patients before related appointments
• Built strong relationships with patients through effective communication skills that foster trust in the clinic''s commitment to quality care.
• Handled billing for patient visits and procedure consultations

• Assigned physician in charge of the outpatient clinic serving legally registered refugees in general internal medicine and general surgery specialties
• Provided expert consultation for challenging cases, contributing to accurate diagnoses and effective treatment plans under extremely stressful conditions
• Improved patient outcomes and delivery of care through improved clinical quality processes
• Served as a strong advocate for patients by striving to increase disease awareness and resource programs
• Performed comprehensive health check-ups, prescribed necessary medications, and referred cases to specialized physicians/surgeons as needed
• Conducted emergency detention center visits to perform physical and mental health check-ups, referring critical cases for hospital admissions, and securing a proper environment for their stay while managing critical care cases as needed