Study Startup Specialist

Employer Industry: Contract Research Organization

• Home-based position offering flexibility in work location
• Opportunity for career advancement and growth within the organization
• Engaging work environment focused on employee development and success
• Involvement in critical study startup processes within the clinical research field
• Chance to work with a variety of therapeutic indications, enhancing professional experience

• Support all processes critical for site activation
• Assist the Feasibility department with feasibility research and site identification
• Maintain project-specific tracking systems and electronic Trial Master File (eTMF) during the study startup phase
• Provide administrative support with site agreements and budgets
• Ensure effective communication and documentation exchange with investigational sites and vendors throughout the study startup phase

• College/University degree or an equivalent combination of education, training, and experience
• At least 1 year of industry experience in clinical research and a minimum of 1 year of Study Startup experience
• Strong communication and organizational skills
• Ability to negotiate and build relationships at all levels

• Experience working with investigational sites and regulatory submissions
• Knowledge of electronic Trial Master File (eTMF) systems
• Familiarity with clinical study protocols and documentation requirements

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