Clinical Research Specialist - MCRS/Safety at Medtronic in Mounds View, Minnesota

Job Description:

The person in this role must be based in the Minneapolis, Minnesota area. They will be a primarily remote resource (work from home); however, they will occasionally be required to work from the Medtronic facility located in Mounds View, Minnesota.

CAREERS THAT CHANGE LIVES
In this exciting role as Clinical Safety Specialist, you will partner with Clinical Safety Managers and Clinical Safety Specialists (CSS) to satisfy applicable regulatory standards and Medtronic internal requirements for the identification, evaluation and reporting of clinical safety-related events identified in Medtronic-sponsored clinical trials.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

A DAY IN THE LIFE
• Oversees, designs, plans, and develops clinical evaluation research studies.
• 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 drug 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.
• 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.
• Assists (Lead) Clinical Safety Specialist with reviewing and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
• Enter appropriate events into the clinical safety database as indicated.
• Under the direction of a Clinical Safety Specialist interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
• Assists the Clinical Safety Specialists to ensure consistency in the assessment, recording and coding of SAEs and adverse events AEs.
• Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
• Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).
• Assists with preparation of the clinical safety plan for assigned protocol(s).
• Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
• Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms. Assists with the writing of safety sections of clinical protocols
• Performs other duties as assigned.

MUST HAVE (Minimum Qualifications)
• Bachelor's degree
• 2+ years of experience with a bachelor's degree or 0+ years of experience with an advanced degree

NICE TO HAVE (Preferred Qualifications)
• Bachelor's degree in a technical discipline
• Safety experience
• Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
• Good written, oral, and interpersonal communication skills including knowledge of medical terminology
• Proficient with MS Office products, word processing, spreadsheets, etc.
• High attention to detail and accuracy; ability to manage multiple deliverables concurrently
• Good prioritization and organizational skills
• Excellent problem-solving skills
• Flexible and dependable
• Works effectively on cross-functional teams

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.

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.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

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

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).

EEO STATEMENT
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.