Job Description:
• Assist with the management and execution of clinical studies in accordance with applicable regulations
• Coordinate project deliverables such as team meetings, budgets, and timelines
• Assist with the development and planning of clinical study strategies and protocols
• Oversee and provide clinical input for the design of Case Report Forms and electronic databases
• Assist with preparation of regulatory applications and documentation needed to conduct studies
• Monitor or co-monitor clinical study sites for compliance with approved study protocols
• Maintain accurate study tracking documents and systems
• Prepare and give clinical presentations as required
• Support Data Monitoring Committees if applicable
• Assist management of study vendors for compliance to study plans
Requirements:
• Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management
• Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation
• Working knowledge of medical terminology
• Capability and willingness to learn device function
• Ability to interface effectively with medical professionals
• Strong analytical and organization skills, with excellent attention to detail and accuracy
• Project oversight and tracking capability
• Experience with electronic data capture (EDC) and clinical trial management systems (CTMS)
• Ability to travel as necessary to clinical centers to establish and manage clinical studies
• Experience as a Project Coordinator/Manager is a plus.
Benefits:
• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules
Apply Now
Apply Now