Associate Clinical Research Specialist
Occupations:
Clinical Research CoordinatorsRegulatory Affairs SpecialistsMedical Scientists, Except EpidemiologistsClinical Data ManagersHealth Technologists and Technicians, All OtherIndustries:
Offices of PhysiciansNursing Care Facilities (Skilled Nursing Facilities)Junior CollegesColleges, Universities, and Professional SchoolsSpecialty (except Psychiatric and Substance Abuse) HospitalsAt 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 LifeIn this exciting role as the Associate Clinical Research Specialist, you will be responsible for supporting clinical activities related to one or more clinical studies and performing/managing the daily field operations associated with support of the assigned studies.Diabetes Business:The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.Ability to travel up to 25% domesticallyJoin 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 HereA Day in the LifeSupports Clinical Research Specialist (CRS)/Clinical Study Manager (CSM) to ensure successful conduct (Planning, Execution, Closure) of assigned clinical studiesSupports registered and non-registered clinical studies of productsSupports audit/inspection deliverables tied to the Trial Master FileBuilds and maintains optimal relationships and effective collaborations with various internal and external parties.Assists in the development, updates and tracking of study-related materials and plans (training materials, study plans, patient materials, etc.) and ensure appropriate approvals before implementationOversee and/or maintains trackers for and file documents for sponsor and site training, IRB approvals, site documents, and monitoring activitiesOversight of Institutional Review Board (IRB) deliverables such as submission, (invoice) tracking and associated checklist(s) Supports efforts for vendor management activities such as supply procurement/shipment, system access, Works with Operations with device management (e.g., forecasting, procurement, shipment and receipt, accountability, failure analysis, SAP transactions).Assists with configuration of the Clinical Trial Management System (CTMS) for the studyAssess and oversee system access (RAVE, BOX, G-suite)Ad hoc projects as assigned in the optimization of procedures and processesMust Have: Minimum RequirementsTo be considered for this role, please ensure the minimum requirements are evident on your resume.Bachelor’s degree required0 years of experienceNice to HaveBachelor’s degree in a scienceClinical research / clinical trials experience at Medtronic or within medical device industryExperience with regulatory compliance guidelines for clinical trials Knowledge of DiabetesExperience with Good Clinical Practice (GCP)Experience in working in cross functional environment, with Research and Development, Regulatory, International and Legal organizations.Proficiency in MS Office (e.g., MS Outlook, Word and Excel)Utilization of the following systems: RAVE, Siebel CTMS, Veeva, Regulatory Affairs Domain (RAD) Able to read, analyze and interpret general business documents, technical procedures, and specificationsAble to write reports, business correspondence and procedure manuals effectivelyWilling to be flexible with work hoursPhysical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$62,400.00 - $93,600.00This 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).About MedtronicMedtronic benefits and compensation plansWe 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.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.At Medtronic, most positions are posted on our career site for 3-7 days.