Clinical Research Specialist
About The Position
In this exciting role as a Clinical Research Specialist within the Structural Heart team, you will have primary focus and responsibility for study start up and execution on a key clinical program to support the development and advancement of best-in-class transcatheter tricuspid therapies. You will work under the direction and closely with the Clinical Research Manager to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. The Structural Heart team offers minimally invasive approaches to restore proper structure and function of the heart. We focus on the transcatheter replacement or repair of heart valves. This role will be within the Mitral and Tricuspid clinical group and be part of the Tricuspid Study Team. 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.
Requirements
- Bachelor's degree and a minimum of 2 years of clinical research experience Or advanced degree with 0 years of experience
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
Nice To Haves
- Clinical trials experience within Medtronic or another medical device industry
- Degree in life sciences, clinical research, or related medical/scientific field
- CCRA certification
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
- Experience in clinical operations
- Experience developing clinical strategies and study design
- Experience in structural heart therapies
- Experience working with global teams
- Project management experience
Responsibilities
- Assist in designing, planning and developing clinical evaluation research studies for products that are under clinical investigation.
- Prepares and authors protocols and regulatory submissions.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Aids in overseeing and interpret results of clinical investigations in preparation for new device or consumer application.
- Oversees and manages operational aspects of clinical trials in conjunction with the Study Team 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 site and vendor selection and oversight.
- Collaborates and partners with a cross-functional team which includes site managers, monitors, statisticians, field teams, and others.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Assists in local evidence dissemination strategies.
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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
