Clinical Research Specialist - Structural Heart & Aortic
MedtronicAbout the role
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, your day centers on preparing sites for data collection, ensuring data quality, and building strong relationships with research coordinators. You support clinical trials by maintaining regulatory compliance and assisting with various study tasks under the guidance of a Clinical Study Manager. Success in this role relies on attention to detail, effective communication, and problem-solving, all while prioritizing participant safety and smooth study progress.The Structural Heart and Aortic integrated operating unit offer minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. This role will be within the mitral and tricuspid clinical group.
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.
This position will be based in Mounds View, MN.
Responsibilities may include the following and other duties may be assigned.
- Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation
- Performs site initiation activities, resolution and follow-up of site issues, and study closure activities.
- Provides support and training for clinical study sites to assure data integrity and protocol compliance. Prepares study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
- Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives
- Perform site file reviews
- 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.
- Performs data review, reviews data discrepancies, ensures data queries are being resolved, works closely with monitors to ensure monitoring action items are resolved, and generates reports.
- Reports on progress and results of clinical investigations
- 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):
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 clinical research experience
Nice to Have (Preferred Qualifications):
- 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.
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
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