Mark Manu

Clinical Research Assistant Phase i & Ii Clinical Trials, Gcp, Phlebotomy, Edc @Clinilabs

NY, US

In my role, I am delegated across multiple clinical trial studies in various therapeutic areas, including cardiology, neurology, psychiatry, and ophthalmology, while ensuring strict compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOP) guidelines. I conduct patient pre-screening and screening, coordinate study visits for over 100 patients monthly, and collect biometric data and biospecimens, including performing phlebotomy procedures. Additionally, I enter data for more than 500 active patients using Electronic Data Capture (EDC) systems, ensuring accurate and timely documentation across multiple clinical databases.I prioritize resolving study-related queries within 24 hours to maintain efficient communication among study teams, patients, and regulatory bodies. My responsibilities also include maintaining an inventory of over clinical trial items, ensuring that all supplies are available and compliant with trial protocols. I collaborate with cross-functional teams to accurately report Adverse Events (AEs) and Serious Adverse Events (SAEs), which contributes to patient safety and trial integrity. Throughout my work, I demonstrate proficiency in patient-focused care while balancing complex clinical responsibilities in a fast-paced, highly regulated environment.