Senior Clinical Trials Assistant
Durham, North Carolina, Us
Entrusted with the review and maintenance of all regulatory files for this for this provider of CRO, clinical trial services, and pharmaceutical consulting, working with clinical sites to ensure compliance with all protocols and regulatory guidelines. Clarify specific study procedures through email and phone communications with Study Coordinators and Principal Investigators. Worked with the Medadata and InForm data collection databases.Key Accomplishments* Provided unsurpassed levels of service to sponsors, including tracking patient visit dates, entry of lab values, and work in numerous tracking tools and databases.* Gained invaluable experience in clinical studies spanning Acute Coronary Syndrome, Oncology single and combined agents, HIV, Asthma-COPD, and Chronic Kidney Disease; worked closely with Clinical Team Leads and Clinical Research Associates to record project compliance and performance.* Served as the primary point of contact for all project communications, correspondence, and associated documentation for the clinical team.* Leveraged superior subject matter expertise to lead training and orientation for all new staff members.* Outstanding performance recognized with the Applause Award on two occasions, as well as the Special Achievement Award.