Clinical Research Specialist
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
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.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 Plymouth, MN.
In this exciting role as a Clinical Research Specialist (CRS), you will be responsible for conducting clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. You will monitor progress and results of clinical investigations in preparation for device application and/or publications. You will be responsible for managing and meeting the objectives of a clinical study.
Role and Responsibilities
Responsibilities may include the following and other duties may be assigned.
- Assist in designing, planning, and developing clinical evaluation research studies for products that are under Clinical Investigation.
- 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 device or consumer application.
- Oversees and manages 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.
- Serves as liaison between program management and planning, study team, and leadership
- Collaborates and partners with a cross-functional team which includes site managers, monitoring, safety, stats, and others
- Assist in reviewing status of projects and budgets; manages schedules and prepares status reports.
- 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.
- Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
- Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
- Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation
.
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 experience
Nice to Have (Preferred Qualifications):
- 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 a medical device industry
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines fo
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