Careers that change lives in this exciting role as a clinical research specialist (crs) in the cardiac surgery operating unit, you will have a primary focused responsibility working with cross-functional partners to oversee and execute clinical research studies with an emphasis on the cardiac surgery areaThe crs facilitates the development of clinical operations through study plans and drives the execution of clinical projectsThe crs is responsible for clinical study management and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with medtronic business needsThe crs sets work direction for the study team and owns the study data to ensure that all data collected is comprehensive, accurate, and up to dateJoin a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every dayIt`s no accident - we work hard to cultivate a workforce that reflects our patients and partnersWe believe it`s the only way to drive healthcare forward and remain a global leader in medical technology and solutionsTo learn more about inclusion & diversity at medtronic click here location: mounds view, minnesota (remote possible) travel: up to 25%A day in the life responsibilities may include the following and other duties may be assigned.
Facilitates the development clinical operations through study plans and drives execution of research studies.
Prepares and authors clinical trial documents.
Oversees and interpret results of clinical investigations in preparation for new device or consumer application.
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.
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 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.
May assist with site initiation activities, resolution and follow-up of site issues, and study closure activities.
May provide support and training for clinical study sites to assure data integrity and protocol compliance.
Assists in development of study materials and/or training and tracks and maintains study documentation.
Performs data review, reviews data discrepancies, generates reports.
May interface with representatives from key functional groups including product development, manufacturing, sales & marketing, distribution, and regulatory affairs.
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 with 2 + years of relevant experience in clinical research (gcps and regulatory compliance guidelines for clinical trials) or
Advanced degree with a minimum of 0 years clinical research (gcps and regulatory compliance guidelines for clinical trials) experience
Nice to have (preferred qualifications):
Bachelor’s degree in engineering, life sciences, or related medical/scientific field.
Experience working on medical device trials
Solid project management skills
Successful cross functional team interaction and influencing skills
Effective interpersonal skills with the ability to influence and lead others who may or may not be part of direct team
Excellent decision making/analysis skills
Proficient knowledge of medical terminology
Knowledge of gcps and regulatory and compliance guidelines for clinical trials
Computer experience with knowledge of word processing and applications such as word, excel and powerpoint.
Demonstrated independent working skills.
Ability to work well in a dynamic, fast paced work environment
Ability to shift priorities and work plan based on department needs
Excellent written and verbal communication skill
Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure
Accuracy and attention to detail essential
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp us shape the future.
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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer and communicate with peers and co-workersContact 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 valuesWe recognize their contributionsThey share in the success they help to createWe offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stageLearn more about our benefits at benefits.medtronic.com
