Hani M Zakhem

Certified Clinical Research Professional with ~12 years of clinical research experience, ~10 years in study coordination and execution, ~2 years supporting project management teams with CTMS and eTMF maintenance, and ~1 year in monitoring and quality assurance. Areas of therapeutic expertise include oncology (disease areas include breast, neuroendocrine, gastrointestinal, lung, skin, genitourinary, genecology, head and neck, central nervous system, and hematology), cardiovascular disease, endocrinology, transfusion medicine, orthopedics, infectious disease, dermatology, gastroenterology, allergy, neurology, ophthalmology, and rare disease.

Certified Clinical Research Professional with ~12 years of clinical research experience, ~10 years in study coordination and execution, ~2 years supporting project management teams with CTMS and eTMF maintenance, and ~1 year in monitoring and quality assurance. Worked at 3 site management organizations, 4 teaching hospitals, and 2 contract research organizations. Areas of therapeutic expertise include oncology (disease areas include breast, neuroendocrine, gastrointestinal, lung, skin, genitourinary, gynaecology, head and neck, central nervous system, and hematology), cardiovascular disease, endocrinology, transfusion medicine, orthopaedics, infectious disease, dermatology, gastroenterology, allergy, neurology, ophthalmology, and rare disease.

Education   

• Medix College | Phlebotomy & ECG Certificate | London, ON |                                              Jan 2010 – May 2010  
• Academy of Applied Pharmaceutical Science |Clinical Research Diploma | Toronto, ON | Feb 2008–Nov 2008
• The University of Western Ontario | Bachelor of Science – Biology | London, ON |             Sep 2003 – Nov 2007

Professional Certification and Membership

• Society of Clinical Research Associates | Certified Clinical Research Professional | Jun 2012 – Exp May 2024

Course Certification

• Canada GCP (Good Clinical Practice) Guidelines                       CITI Program                  Feb 2024 – Exp Feb 2029
• Essentials of Grant Proposal Development                              CITI Program                    Jan 2024 – Exp Jan 2025 
• Essentials of Clinical Trial Budgets                                             CITI Program                    Jan 2024 – Exp Jan 2025
• Transportation of Dangerous Goods TDG/IATA – Canada      CITI Program                  Aug 2023 – Exp Aug 2024
• Human Subjects Research – Biomedical Research                 CITI program                  Dec 2022 – Exp Dec 2025
• Health Canada Food & Drug Regulations, Part C, Division 5    CITI Program                  Nov 2022 – Exp Nov 2024
• Excel Essential Training (Office 365/Microsoft 365)                 LinkedIn Learning (IQVIA)                          Jul 2022
• Doing More with SAS Programming                                             Coursera & SAS®                                        Feb 2022
• Teamwork Skills: Communicating Effectively in Groups          Coursera – CU Boulder                              Mar 2021
• International and Cross-Cultural Negotiation                           Coursera – Essec Business School           Mar 2021
• Negotiation Fundamentals                                                          Coursera – Essec Business School           Feb 2021
• Responsible Conduct of Research – Ethics and Regulatory   CITI Program                     Oct 2020 – Exp Oct 2030
• Managing Project Risks and Changes                                        Coursera – UC Irvine                                   Oct 2020 
• Getting Started with SAS® Programming                                 Coursera & SAS®                                          Oct 2020
• Budgeting and Scheduling Projects                                           Coursera – UC Irvine                                   Sep 2020
• Initiating and Planning Projects                                                  Coursera – UC Irvine                                   Aug 2020 
• Canada Privacy – Healthcare and Research                            CITI Program                                                 Dec 2019 
• TCPS2 (Tri Council Policy Statement): CORE                           Health Canada                                              Feb 2018 
• Protecting Human Research Participants                                 NIH (National Institutes of Health)           Sep 2014