Job Description

• 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.