Clinical Research Specialist

Medtronic•Mounds View, MN

12d•Onsite

About The Position

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, 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. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 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.

Requirements

Bachelor's degree plus 2+ years of related experience

Nice To Haves

Bachelor's degree in degree in engineering, life sciences, or related medical/scientific field
Clinical experience
Site Management experience (site or sponsor)
Knowledge of/experience with CTMS/EDC/TMF
Experience with Good Clinical Practice (GCP)

Responsibilities

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.
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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)