In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility in preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. The CRS works under the direction of a Clinical Study Manager and assists with numerous tasks associated with the execution of a clinical trial.
The Study & Scientific Solutions (S&SS) is a function within Medtronic Core Clinical Solutions (MC2). S&SS is an internal service provider to all of Medtronic and assigns resources to assist Business Units execute on clinical trials and scientific projects when they have an increase in workload.
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.
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Location: Mounds View, MN
Travel up to 10%
A Day in the Life
Responsibilities 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 maintains optimal relationships and effective collaborations with various internal and external parties.
Drives local evidence dissemination & awareness.
Other duties:
After reviewing approved supplier list, develop and send out Request for Proposal (RFP) to targeted vendors, qualify vendors and perform vendor selection as required
Negotiate and Execute Vendor Contracts and payments: After vendor selection, work with contracts and legal to create, negotiate and execute contracts for both internal and external vendors
Perform activation tasks for sites and site personnel
Training
Gather activation documents
Send activation notification
Site maintenance
Ensure data queries are being resolved
Work with monitors to ensure monitoring action items are resolved
Answer site questions
Perform site file reviews
Review the Case Report Form (CRF) Specifications per the Case Report Form (CRF) optimization governance process
Approve Investigator Brochure (IB)/Report of Prior Investigations as required by SOPs
Develop/review/approve the Document Management Plan for the study
Register on appropriate clinical registration system (e.g., clinicaltrials.gov or equivalent system)
Develop site training materials per Clinical Investigation Plan (CIP) (e.g., Clinical Investigation Plan (CIP) training, database training, etc.)
Track and manage enrollment according to plans and take actions as required
Provide necessary information to Publications Specialist for development of Abstract / Manuscript / Presentation: The development and coordination of a scientific communication based on clinical trial data (including ICMJE and other requirements)
To be considered for this role, the minimum requirements must be evident on your resume.
Bachelor's degree and a minimum of 2 years of clinical research experience or advanced degree with 0 years of experience
Nice to Have (Preferred Qualifications):
Degree in engineering, life sciences, or related medical/scientific field.
Clinical Research experience at Medtronic or within the medical device industry or pharmaceutical industry.
CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA , or equivalent preferred.
Experience in sponsor-initiated clinical trial experience managing clinical site personnel
Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.
Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.
Ability to incorporate and adhere to applied standard practices and regulatory standards.
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 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. (ADA-United States of America).
Travel up to 10%
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 at benefits.medtronic.com
