About this role
5+ years of clinical research experience. Preferably a Clinical Research Coordinator or Clinical Research Associate (CRA)- Oncology experience is preferred. Experience with regulatory activities, particularly local submissions, requiring strong attention to detail and adherence to multiple protocols. Hands-on experience with Electronic Data Capture (EDC) systems and/or Clinical Trial Management Systems (CTMS). Strong familiarity with various protocol types, including industry-sponsored studies, Investigator-Initiated Trials (IITs), NIH studies, Cooperative Group studies, and different trial phases. In depth understanding of protocol documents, including the Schedule of Events (SOE), Study Design, Synopsis/Summary, and other key sections. Excellent attention to detail and critical thinking skills. Strong knowledge of clinical research terminology, including AE, DB, OLE, LTFU, I/E Criteria, and related concepts. Ability to independently interpret reference documents and SOPs to manage workflows effectively. Good analytical and mathematical skills, including calculating visit windows, study cycles, and screening timelines. Experience providing meaningful feedback and constructive recommendations. Technical knowledge of configuring or building studies within CTMS and/or EMR systems (e.g., Epic) is highly desirable. Ability to work independently in a remote environment.