Careers That Change Lives

In this exciting role as Clinical Research Specialist (CRS), you will work on a pre-market pivotal study to collect evidence to support label expansion.

This position is responsible for several aspects related to the execution of clinical studies e.g., selection, qualification, and activation of US sites, support execution of clinical studies by ensuring data and documents coordination. Contributes to the completion of work group/team objectives, through building strong relationships with the investigators/ sites study staff. Looking for someone with growth potential, strong customer focus. This position is accountable for supporting execution of all site management related activities.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here

Neuroscience develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Within Neuroscience, the Cranial and Spinal Technologies (CST) division shapes surgery for the better; delivering cranial, spinal, and orthopedic solutions. We are a leader in therapeutic biologics. We partner with other healthcare stakeholders to accelerate ground-breaking innovations that can improve surgical efficiencies and help create better outcomes for more patients.

Location: Flexible location – anywhere in the US. remote position

Ability to travel up to 25-50% (mostly domestically in the US)

A Day in the Life

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

• Is in regular contact with the investigating centers who participate in Medtronic clinical studies.
• Performs qualification, selection, activation, and closure of investigating centers.
• Manages and follows-up with investigating centers, especially sites issues.
• 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.
• Assists in preparation of study materials and/or training; tracks and maintains study documentation.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance.
• Provides support for the management of regulatory submissions to the country health authorities.
• Participates in overall clinical management plan and protocol development.
• Assists with periodic internal audits of clinical study files for completeness and accuracy.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Assists clinical management with other duties as requested.
  

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor’s degree required with a minimum of 2 years of clinical research experience or advanced degree with 0 years of experience
  

Nice to Have (Preferred Qualifications):

• Degree in biology, neuroscience, engineering, life sciences, or related medical/scientific field
• Clinical Research experience at Medtronic or within a medical device industry, preferably in spine area and/or experience with pre-market studies
• Experience in managing multiple clinical research sites with proven results in study execution
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• Experience with operating room etiquette
• Experience with CTMS, RAD, Oracle RDC, Medidata RAVE EDC, VEEVA
• Proficiency in MS Office applications: Teams, 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 physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)