Clinical Studies Spt Coord IV at Medtronic in North Haven, Connecticut

Job Description:

Careers that Change Lives

The Clinical Studies Support Coordinator IV in the Surgical Robotics Operating Unit supports clinical studies by executing and maintaining one or more of the following areas: document management, data coordination/management, and site management. Serves as liaison between clinical, site, and field personnel, as appropriate, by coordinating and contributing to ongoing, timely and consistent communication. Maintains general knowledge and application of industry practices, regulations, and standards. General application of clinical trial management concepts and principles.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here

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.

A Day in the Life
• Provide project/program coordination and support to Global Clinical Study team

• Maintains study-specific correspondence and other required documentation

• Assists/coordinates in the organization and distribution of clinical study documentation

• May assist in tracking study activity, such as start-up progress by ensuring receipt of proper study documentation, agreements, and site approvals

• Attends team meetings, taking notes on discussion points and action items-ensuring proper follow through

• May work with clinical teams to create and distribute newsletters and communications to sites

• Support, monitor, and analyze daily projects and contracts using Excel, Power Point, SCTMS, RAD, Vision Tracker, SharePoint, and shared network drive

• Create, run, and monitor metrics and maintenance reports on an ongoing basis

• Identifies issues in documents, memos, correspondences, and telephone calls which require action. Recommends alternatives and executes an alternative when appropriate

• Support process improvements efforts to enhance systems and reduce lead time

• Perform various study duties including facilities coordination, project document organization and reconciliation, setting up files, ordering supplies/equipment, photocopying

• Solves problems of moderate scope and complexity following established policies and procedures

• Works under limited supervision

• Minimum of 6 years of relevant experience

• Associate's or Bachelor's degree preferred
• 7+ years' experience in clinical study administration or related experience
• Clinical research/study coordination experience at Medtronic or medical device industry
• Experience with Diabetes products/therapies
• Experience working with Siebel CTMS and Clinical RAD applications
• Knowledge of medical terminology
• Basic knowledge of GCP and regulatory compliance guidelines for clinical trials
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)