Gelila Demissie Tiyo

Clinical Trial Assistant @MAC Clinical Research

Manchester, GB

Primary Responsibilities-Conduct clinical trial visits across all phases of trials in strict adherence to the study protocol and ICH-GCP guidelines-Process clinical trial specimens meticulously following the study protocol and perform thorough quality control checks-Arrange for the national and international shipment of clinical trial samples, ensuring compliance with IATA regulations and local regulatory standards- Address clinical trial inquiries and sponsor-raised questions promptly and comprehensively- Prepare source documents in accordance with the study protocol for trial visits- Efficiently coordinate study participant visits based on their visit schedules- Conduct rigorous quality control assessments on source documents and informed consent forms- Handle Investigational Medicinal Products (IMP) accountability and dispensing with precision- Perform ECG, vital sign assessments, and venipuncture procedures on clinical trial participants with diligence-Collaborate closely with clinical research physicians to support trial screening visits- Actively participate in site initiation and close-out visits, ensuring seamless trial management- Conduct quality control checks on patient source documents to maintain data integrity- Investigate the root causes of errors in clinical trial activities and draft corrective action and preventive action plans- Establish and organize site investigator files and other necessary documentation for the study- Developed and maintained effective relationships with both internal and external stakeholders-Utilized various software programs to track and maintain clinical trial documents- Collaborated with CRAs to ensure the accuracy of collected data and meet trial milestones- Managed data entry activities of clinical trial data for two clinical trials involving over 100 participants- Developed and maintained clinical trial tracking systems to ensure accuracy and completion of study objectives.

University of Dundee

Master's degree, Public Health

University of Dundee

Master's degree, Public Health

Haramaya university

Bsc. in medical Laboratory Science, Clinical/Medical Laboratory Science/Research and Allied Professions

Haramaya University

Bachelor of Science - BS, Medical Laboratory Science