Location: Cleveland, OH
Responsibilities:
• Monitors clinical studies to ensure subject safety, compliance with study protocols, regulatory requirements, and Good Clinical Practices.
• Prepares monitoring reports following study site visits as applicable.
• Trains clinical site staff on study protocols, good clinical practices, and use of investigational devices.
• Maintains regulatory binders for all active clinical studies.
Requirements:
• Bachelor’s Degree or higher in Life sciences or related technical or clinical field.
• At least 5 years related research and monitoring experience and at least 3 years experience as a CRA, preferably in the Medical Device industry.
• Experience with the design, management and conduct of medical device or drug related clinical studies.
• Knowledge of FDA guidelines and Good Clinical Practices.
• Ability to travel up to 40%
• Ability to handle several priorities within the clinical research process.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to work independently, prioritize, and work within a team environment.
Why Join Our Team?
• Entrepreneurial work environment.
• Small, collaborative office environment.
• Competitive compensation and benefits.
• Flexible work/life balance.
• Wellness Program.
