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) in our Robotic Surgical Technologies Business Unit, you will have primary responsibility in the execution and oversight of global clinical investigational sites. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.  Most of the time is spent delivering and executing the projects, while adhering to policies and using specialized knowledge and skills normally acquired through advanced education and experience.  Assumes project management responsibilities for site management activities as needed.

Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes. Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.

We're making that exciting future possible — and disrupting one of the biggest and fastest growing markets in healthcare — with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions. 

Location: Mounds View, MN / Boston, MA / Lafayette, CO / North Haven, CT. Team could consider a candidate to work remotely from the U.S., but will have a strong preference for local/on-site talent.

Travel: 30% (domestic and international)

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

• Oversight of assigned activities for a clinical study from preparation, activation, enrollment, submission, maintenance, and study closure phases. 
• Prepares required clinical documents in consultation with the cross-functional project team, investigators, and the clinical team.
• Completes project tasks and provides site management along with ensuring successful interface with key functional groups, i.e., Start-up specialists, Data Management, Safety, Monitoring, etc.
• Trains study site personnel, ensures site compliance adherence to the study Clinical Investigational Plan and regulatory requirements, maintains follow-up compliance, and represents Medtronic as a primary contact for assigned sites.
• Assists with the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies, e.g., monitoring reports, device tracking and CAPA tracking systems.
• Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports.
• Ensures appropriate execution of the clinical study with internal and external resources including, but not limited to monitoring staff, CROs, and core laboratories.
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions.
• Regularly communicates study status to management.
• Oversees, designs, plans and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves 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.
• May be responsible for clinical supply operations, site and vendor selection.
• People working within region/country may also have the responsibilities that include:
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.

Must Have (Minimum Requirements):

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

OR

• An advanced degree with 0 years of clinical research experience

Nice to Have (Preferred Qualifications):

• Degree in engineering, life sciences, or related medical/scientific field
• 3+ y