Clinical Trial Activation Specialist

Responsibilities

• Activations and Modifications Support (70%)
  • Facilitate protocol acceptance, activation, and modification implementation for clinical research protocols.
  • Oversee effective operation of protocols involving collaboration with clinical research administration, departments, and central offices.
  • Serve as the primary resource for maintaining study status information across assigned trials.
  • Document delays in activation and identify bottlenecks in activation and implementation processes.
  • Manage new study submission and activation after confirming all institutional requirements are met.
  • Develop and maintain a tracking system to monitor protocol activations and modifications.
• Communication (20%)
  • Maintain up-to-date status updates between central offices, research staff, and departments throughout the study life cycle.
  • Navigate protocols through clinical research systems by coordinating with multiple stakeholders.
  • Prepare for and attend clinical department meetings for assigned departments.
  • Serve as a content expert to guide departments through the activation process.
• Maintenance of Regulatory and Study Documentation (10%)
  • Assure appropriate written regulatory documentation and standard operating procedures are maintained.
  • Maintain up-to-date knowledge of institutional policies, databases, and systems used in clinical trial workflows.
  • Utilize systems such as CTMS, the IRB system, and other indicated research platforms.

Qualifications

• Required: Bachelor's Degree
• Preferred: Master's Degree
• Required: Four years in regulatory compliance or clinical research start-up
• May substitute education degree with additional years of experience on a one to one basis
• Required: CCRP - Certified Clinical Research Professional or CCRC - Certified Clinical Research Coordinator or CCRA - Certified Clinical Research Associate