Clinical Research Spec
About The Position
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The ICT portfolio delivers differentiated cardiovascular technologies that help clinicians detect and manage cardiac conditions earlier, treat patients more effectively, and improve outcomes. By combining advanced device innovation, actionable data, and connected care capabilities, the portfolio supports better clinical decision-making and creates value for patients, providers, and healthcare systems. 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. In this exciting role as a Clinical Research Specialist within the Interventional Cardiology Therapies (ICT) Operating Unit, you will have primary focus and responsibility for study execution and clinical study site management on a key clinical program to support the development and advancement of best-in-class ICT device-based technologies. You will work under the direction and closely with the Clinical Study Manager to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies.
Requirements
- Bachelor's degree and a minimum of 2 years of clinical research experience
- Or advanced degree with 0 years of experience
Nice To Haves
- Degree in engineering, life sciences, or related medical/scientific field
- CCRA certification (Certified Clinical Research Association), SOCRA
- Clinical research/clinical trials experience at Medtronic or within the medical device industry
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
- Experience managing multiple clinical research sites with proven results in study execution
- Experience in clinical operations
- Experience developing clinical strategies and study design
- Experience working on a global study team
- Experience in Research and Development (R&D)
- Project/program management skills/experience
- Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
Responsibilities
- 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.
- Sets up and maintains accurate clinical study files.
- Coordinates activities of associates (assigned clinical site 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.
Benefits
- 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)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
