Study Start Up Specialist

📋 Description

• Coordinate day-to-day study start-up activities, ensuring deliverables are completed according to
• Oversee site-level start-up activities, from initial site identification through activation, under
• Coordinate the collection of confidentiality disclosure agreements (CDAs), site questionnaires, and
• Manage informed consent form (ICF) negotiations, institutional review board (IRB) or ethics
• Support the implementation of regional study start-up strategies and contribute to the consistent
• Prepare study-level essential document templates and assist with the preparation of regulatory

🎯 Requirements

• Bachelor's degree in a relevant field, or an associate degree combined with at least two years of
• Practical knowledge of clinical trial conduct and a general understanding of drug development
• Familiarity with ICH/GCP guidelines and applicable regulatory requirements for clinical research.
• Proven project management skills, including the ability to coordinate multiple activities, monitor
• Strong administrative and organizational abilities, with excellent attention to detail and a
• Excellent written and verbal communication skills, with the ability to collaborate effectively with

🎁 Benefits

• Remote work arrangement.
• Full-time employment.
• Opportunity to contribute to clinical research and the development of therapies that may improve
• Exposure to international clinical trial operations and collaboration with cross-functional, global
• Opportunities to develop expertise in study start-up processes, regulatory compliance, and clinical