Pre-clinical Study Coordinator -- Scientist II at Medtronic

Posted in General Business 12 days ago.

Type: Full-Time
Location: Coon Rapids, Minnesota

Job Description:

Careers that Change Lives
At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes our company an exciting and rewarding place to be. Our Scientists and Engineers create a market-leading portfolio of innovations that help bring the next generation of life-changing medical technology to patients worldwide. Together, we can change healthcare worldwide.

The Preclinical Study Coordinator - Scientist II role is responsible for assisting the study directors in the management and execution of numerous diverse projects across all of Medtronic's businesses. The study coordinator assists Study Directors in the interpretation, analysis, documentation, and reporting of results, and participates in preclinical animal and cadaveric research events. This work is accomplished with supervision and direction from the study directors.

This is a strong individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. They will formulate, deliver and/or manage projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, and using specialized knowledge and skills.

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

  • Assists the Study Director with the coordination of study execution, initiation, design, development, and implementation of Preclinical research projects. This includes coordination and collaboration across a multidisciplinary team comprised of Quality Assurance, Surgical and Veterinary Support, Animal Care, Clinical Chemistry Pathology, and Project Managers, Engineers and other researchers.
  • Under Study Director oversight, manages portions of studies and events of low to moderate complexity and prepares near final drafts of protocols, animal use forms, and reports.
  • Ensures the availability of the proper devices and equipment to successfully conduct the study, to control test devices to ensure integrity. Advises sponsors on device selection.
  • With input from the Study Director, determines and schedules the study events and addresses required changes. In conjunction with the Study Director, reviews all aspects of the data package to determine if protocol requirements and expected scientific objectives and practices are met.
  • Prepares corrective documentation as necessary. Provides input to the overall preclinical strategies for collaborative sponsor groups, such as animal models, method development, technology assessments. May participate in the development of patent applications.
  • May coordinate interdepartmental activities and research efforts.
  • Understands and adheres to department best practices, PRL policies, and facility standards for regulatory compliance.
  • Under the guidance of the Study Director, reviews Preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices, and interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.
  • Prepares necessary and corrective documentation, such as draft memos, deviation reports, and final reports, as required.
  • Reviews submissions to regulatory bodies for correlation and tractability to preclinical data, and compliance to the FDA Good Laboratories Practices for Non-clinical Studies.
  • Prepares necessary corrections for Study Director approval. Develops core physiological or biomedical engineering knowledge that supports the product plans and research objectives of the businesses he or she supports.Participates in the development of surgical and disease-state animal models that will meet the needs of the studies and research goals.
  • Maintains substantial knowledge of state-of-the art principles and theories and may contribute to scientific literature and conferences.
  • Assists in planning study/project schedule to meet group business goals.Suggests and participates in business operations and improvements.
  • Contributes to business relationships, practices, processes, and/or information systems of the department and the facility.
  • Actively participates in and/or leads continuous improvement initiatives. Must be available to work variable hours and weekends to support business needs.
  • Due to the nature of the work required by this position, weekend and evening coverage may be required. Ability to travel up to 20%, including international travel, for training, classes, and other departmental business, as needed.

Good Laboratory Practice
Employees must conform to the SOP's and documentation that applies to their work areas. This includes proper documentation techniques, updating the SOP's, training on the SOP's and knowledge of the GLP regulations that apply to their area.

Environmental Health and Safety
Medtronic is committed to a safe, healthy and environmentally conscious workplace that is in compliance with all applicable laws and regulations. All employees are expected to develop a pro-active, cooperative attitude toward issues of health, safety and the environment. Participation in the PRL EHS program through EHS suggestions, work procedure EHS analysis at SOP reviews and EHS committee membership is the responsibility of every employee.

In accordance with the Medtronic EHS Infrastructure and Responsibilities Policy, employees must:
1. Understand and follow EHS policies and procedures
2. Actively participate in EHS programs and training
3. Provide suggestions and to continuously improve EHS programs

Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

  • 4-year Bachelor's degree in engineering, biological sciences or related medical/scientific field.
  • Theoretical job knowledge typically obtained through advanced education.
  • Demonstrated ability to effectively support and provide a degree of leadership to a cross-functional team when necessary.
  • Written and oral communication skills.
  • Able to manage multiple tasks and effectively represent the Study Director when required.
  • Proficiently practical knowledge of medical terminology, scientific principles and procedures, as well as project goals.
  • Functional knowledge of GLP and regulatory compliance guidelines, and the regulatory environment.
  • The candidate must be comfortable working with animals and human tissue

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It 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 team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. Learn more about our benefits here .

MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

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