Senior Clinical Research Associate - Medical Device

Senior Clinical Research Associate position within a sponsor-dedicated model at a large functional service provider. The role involves leading clinical trial monitoring activities for surgical device studies across the central United States, with emphasis on protocol adherence, site performance assessment, and team guidance.

Responsibilities

• Monitor clinical trial sites to ensure protocol adherence, regulatory compliance, and GCP standard adherence
• Conduct site visits to assess performance, resolve operational issues, and provide ongoing support
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Train and mentor site staff and other CRAs to maintain clinical trial conduct standards
• Build and maintain relationships with site personnel and stakeholders to support trial operations

Requirements

• Bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science
• 3-5 years of CRA monitoring experience in CRO or pharmaceutical environments
• At least 1 year of medical device monitoring experience preferred; complex pharma experience considered
• In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Strong problem-solving and risk mitigation skills in clinical trial settings
• Exceptional verbal and written communication abilities with diverse stakeholders
• Ability to work independently, manage multiple priorities, and travel approximately 60%

Compensation: $110,520-$138,150 base