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Clinical Research Specialist

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Clinical
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19000H2U Requisition #
Location:  Louisville, Colorado
 
Careers That Change Lives
 
Impact patient outcomes.  Come for a job, stay for a career.
 

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

Within RTG, the BRAIN THERAPIES division offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 
A Day in the Life
  • The Clinical Research Specialist works with supervision of management to satisfy applicable clinical and regulatory requirements and Medtronic internal requirements.  Responsibilities may include the following and other duties may be assigned.
  • 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 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.
  • People working within region/country may also have the responsibilities that include: review of clinical plans and study reports, study work instructions and guidelines, as well as performing activities and generating reports for one or more significant subparts of the study (e.g. monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, site initiation and study training, patient informed consents, clinical document management).  Ensure study site activities are in line with project plans (i.e. startup, recruitment, closeout, etc.) and implement contingency plans to maintain schedule as needed.
  • 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.
Location:  Louisville, Colorado
 
Careers That Change Lives
 
Impact patient outcomes.  Come for a job, stay for a career.
 

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

Within RTG, the BRAIN THERAPIES division offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 
A Day in the Life
  • The Clinical Research Specialist works with supervision of management to satisfy applicable clinical and regulatory requirements and Medtronic internal requirements.  Responsibilities may include the following and other duties may be assigned.
  • 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 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.
  • People working within region/country may also have the responsibilities that include: review of clinical plans and study reports, study work instructions and guidelines, as well as performing activities and generating reports for one or more significant subparts of the study (e.g. monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, site initiation and study training, patient informed consents, clinical document management).  Ensure study site activities are in line with project plans (i.e. startup, recruitment, closeout, etc.) and implement contingency plans to maintain schedule as needed.
  • 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.

Must Have: Minimum Qualifications

To be considered for this role, the minimum requirements must be evident on your resume.

  • Bachelor’s Degree and 2 years of clinical research experience or advanced degree with a minimum of 0 years of clinical research experience.
Nice to Have
  • Bachelor’s degree in engineering, life sciences, or related medical/scientific field.
  • Clinical Research experience at Medtronic or within a medical device industry.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
  • Ability to manage multiple clinical research sites with proven results in study execution.
  • Experience writing or updating clinical reports/documents.
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Ability to incorporate and adhere to good clinical practices and regulatory standards.
  • Ability to identify and implement solutions in addressing study issues.
  • Excellent prioritization 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 Day in the Life 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.

Ability to travel up to 25%.

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.

 
EEO

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.

 

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
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