Senior Clinical Research Specialist - CRDN

at  Medtronic

We anticipate the application window for this opening will close on - 20 Nov 2024
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.

CAREERS THAT CHANGE LIVES

In this exciting role as a Sr. Clinical Research Specialist, you will have primary focus responsibility to assist with study management duties for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. You will work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies. Under direct supervision, assumes project management responsibilities for selected studies and site management activities as needed.
Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.
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. To learn more about Inclusion & Diversity at Medtronic Click Here .
Primary location is Mounds View, MN or Santa Rosa, CA; will consider remote position within the United States.
Travel up to 20%.

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 all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

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 all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

TO BE CONSIDERED FOR THIS ROLE, THE MINIMUM REQUIREMENTS MUST BE EVIDENT ON YOUR RESUME.

• Bachelor’s degree
• Minimum of 4 years of clinical research experience OR
• Advanced degree with 2 years of clinical research experience

Responsibilities may include the following and other duties may be assigned.

• Review patient data to ensure study protocol inclusion/exclusion criteria is met and patient is appropriate candidate for therapy
• Oversees, designs, plans and develops clinical evaluation research studies
• Authors and/or reviews study reports
• 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 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
• May be responsible for clinical supply operations, site and vendor selection
• Oversee study vendor deliverables
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties (i.e., clinical site physicians, nurses, echocardiographers, sonographers, etc.)
• Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies
• Participates in overall clinical management plan, protocol and case report form development
• Prepares, manages, and hosts patient screening calls for various medical devices and/or therapies
• Provides support and training for clinical study teams, physicians, and cross-functional partners to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files
• Performs data review, reviews data discrepancies, generates reports
• May interface with representatives from key functional groups including Product Development, Therapy Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs
• Assists clinical management with other duties as requeste