At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Clinical Research Specialist (CRS) you will work closely with Sr & Principal level Clinical Study Managers and Medical and Clinical Affairs leadership, Research & Development, and Product Marketing and Market Development personnel in the development and execution of clinical studies for the Acute Care & Monitoring Operational Unit.

The ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, and refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

Location: Boulder, CO

Travel: 10-25%

Responsibilities may include the following and other duties may be assigned.

• Assists in overseeing, designing, and planning of clinical research studies.
• Authors protocols and documentation related to clinical studies.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Assists in Overseeing and interpreting results of clinical investigations in preparation for new drug device or consumer application.
• Assists in resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• Escalates any study issues quickly to senior Clinical Study Managers and leadership and meets study milestones.
• Maintains an understanding of regulatory requirements across multiple regions; serves as a resource for clinical strategy personnel.
• Assists in Overseeing of clinical study operations, including safety, monitoring, data management, and site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Oversees, designs, plans and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application.
• May be responsible for clinical supply operations, site and vendor selection.

Required Knowledge and Experience:

• Bachelor's degree with 2 years of clinical research experience

OR

• An advanced degree with 0 years of clinical research experience

Nice to Have:

• Degree in engineering, life sciences, or related medical/scientific field
• Clinical Research experience at Medtronic or within the medical device industry
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• CCRA certification (Certified Clinical Research Association), SOCRA.
• Experience managing multiple clinical research sites with proven results in study execution
• Experience working on a global study team
• Experience in managing clinical trial data review
• Basic understanding of biostatistics and trial design
• Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting
• Experience with Clinical Operations and interfacing with CRO teams
• Clinical study management experience
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
• Excellent project management and organization skills

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those