Clinical Lab Clinical Research Specialist (Clinical Research)In this exciting role as a Clinical Research Specialist, you will have primary responsibility to manage day-to-day operations of clinical studies within the Medtronic physiology lab. This role reports to the Clinical Lab Manager. The Clinical Research Specialist will independently develop and maintain study documentation, including protocols and supporting documents.The Clinical Research Specialist will manage clinical study databases and assist with the drafting, distribution and tracking of study paperwork; case report forms, and informed consents and assist in the laboratory and clinical study operations through maintenance of procedures in one or more of the following areas: production, research and development, quality control/assurance, and/or compliance/environmental safety. Location:Boulder / Denver, CO - Travel up to 15% (primarily domestic and occasionally international).Operating UnitAcute Care & Monitoring Operating Unit - Medtronic is working together with the global healthcare community to solve clinically meaningful problems, with technologies and solutions for blood oxygen management, respiratory compromise, and perioperative complications.We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. To learn more about Inclusion & Diversity at Medtronic Click HereCareers That Change LivesOur space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it's like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.A Day in the LifeResponsibilities may include the following and other duties may be assigned. 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 RequirementsBachelor's degree with 2 years of clinical trials/clinical research/lab experienceORAn advanced degree with 0 years of clinical trials/clinical research/lab experienceNice to HaveExperience with clinical research at MedtronicExperience in pre-market/ investigational and post market studiesExperience with database management, subject recruitment and consenting, data collection, and clinical reporting.Knowledge and familiarity with the operations of a medical research laboratoryAbility to follow established guidelines/procedures for the preparation of various administrative forms, as well as learn new tasks independently.Able to read and interpret technical procedures and regulatory requirements.Experience in medical device clinical product trials and governing regulations.Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial.Proficient knowledge of clinical research study processes and study design.Knowledge of data analysis techniques, including basic statistical methodsLeadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management. Demonstrated ability to work effectively on cross-functional teams.Experience in a high-demand and fast-paced environment. Strong problem-solving skills.About MedtronicTogether, 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 RequirementsThe 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)CompensationA 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. Learn more about our benefitshere. This position is eligible for a short-term incentive plan.Learn more about Medtronic Incentive Plan (MIP) on page 6here. The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc. At Medtronic, most positions are posted on our career site for at least 3-7 days.
