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Associate Clinical Research Specialist
4 months ago
Careers that Change Lives
In this exciting role as an Associate Clinical Research Specialist within the Cardiac Rhythm Management Integrated Operating Unit, you will have primary focus and responsibility for document management, study execution and clinical study site management on a key clinical program to support the development and advancement of best-in-class therapies. You will work closely with the Clinical Study Manager to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies.
Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.
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
Primary location is Mounds View, MN; will consider remote position within the United States. Travel up to 10%.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Supports clinical studies by executing and maintaining one or more of the following areas.
* Data coordination- actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements.
* May process compensation & identify and resolve compensation discrepancies.
* Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents.
* Performs site initiation activities, resolution and follow-up of site issues, and study closure activities.
* Prepares study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files
* Assists with periodic audits of clinical study files for completeness and accuracy
* Provides support and training for clinical study sites to assure data integrity and protocol compliance.
* 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.
* Participates in overall clinical management plan, protocol and case report form development.
* May be responsible for clinical supply operations, site and vendor selection.
* 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
* Bachelors degree required
* 0 years of experience required
Nice to Have
* Degree in life sciences, or related medical/scientific field.
* Experience conducting/working on clinical studies and managing clinical trial data review
* Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
* CCRA certification (Certified Clinical Research Association) or SOCRA.
* Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
* Experience with Clinical Operations and interfacing with CRO teams.
* Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
* Excellent project management and organization skills
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).
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. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
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).
