Clinical Research Specialist

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.

Were 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):

Bachelors 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 years’ of experience managing clinical trials within Medtronic or medical device industry

Experience conducting an IDE or pre-market study team

Experience in Surgical therapies/product

Experience managing multiple clinical research sites with proven results in study execution

Experience in managing clinical trial sites

Basic understanding of clinical monitoring and auditing

Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020

Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

Computer skills (MS Office products, word processing, spreadsheets, etc.).

High attention to detail and accuracy.

Ability to manage multiple tasks.

Good prioritization and organizational skills.

Excellent problem-solving skills

Positive outlook.

Flexible and dependable.

Works effectively on cross-functional teams.

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 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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$80,000.00 – $120,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic)

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000 passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000 passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

Build a better future, amplifying your impact on the causes that matter to you and the world

Grow a career reflective of your passion and abilities

Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. Youre shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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