Reporting to the Clinical Manager, the Research Coordinator’s purpose is to facilitate the activation of new studies and the coordination and management of moderately complex interventional clinical trials from activation to closeout adhering to regulatory requirements and the study protocol. The Research Coordinator is responsible for performing study-specific duties delegated by Principal Investigator (PI), and must utilize good organizational, time management, and critical thinking skills to efficiently activate clinical trials and independently coordinate assigned studies, solve problems, and manage multiple priorities at the same time.
Undergraduate Degree in Sciences or Health Sciences
• Clinical research certification required, i.e., ACRP, SoCRA or post-graduate certification in clinical research
• Minimum 3 years previous experience in clinical trials; oncology clinical trials preferred
• Experience using clinical trial data management, ethics submission, and vendor software applications,and sponsor portals
• Previous experience with ethics submissions and completion of regulatory documents
• Fundamental knowledge of clinical research principles, practices, and processes related to study coordination, data collection, and reporting
• Applies thorough knowledge of clinical research principles, practices, and processes to facilitate study activation
• Utilizes relationship-building skills to cultivate effective partnerships with study sponsors and internal and external collaborators
• Excellent communication and problem solving skills
• Working knowledge of project management processes
• Working knowledge of ICH-GCP Guidelines and international research regulations
• Knowledge of medical terminology required
• Excellent organizational and time management skills
• Excellent computer skills including extensive experience with Microsoft Office applications