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Clinical Research Specialist

📁
Clinical
📅
200004FM Requisition #

Careers that Change Lives

 

The Clinical Research Specialist (CRS) manages assigned projects to facilitate the execution of study deliverables.  Oversees clinical study activities in compliance with applicable clinical and regulatory standards, and in alignment with Medtronic business needs.  Works daily with cross functional partners on study activities in preparation for new device application and/or publications.  The CRS is integral in establishing conditions for determining the safety, efficacy, medical usefulness and marketability of medical device products. 

 

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.


A Day in the Life
 

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 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.

Must Have (Minimum Requirements):

  • Bachelor's Degree with a minimum of 2 years of clinical research experience, or advanced  degree with 0 years of clinical research experience

Nice to Have

  • Proficient knowledge of clinical research terminology
  • Experience working on medical device trials
  • Experience working novel data sources
  • 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
  • Solid project management skills
  • Accuracy and attention to detail essential
  • Successful cross functional team interaction and influencing skills
  • Ability to be a self-starter and work independently to achieve on time deliverables
  • Excellent oral and written communications
  • Effective interpersonal skills with the ability to influence and lead others who may or may not be part of direct team.
  • Results-oriented and a strong sense of urgency
  • Ability to prioritize rapidly
  • Strong problem-solving skills
  • Excellent decision making/analysis skills
  • Excellent organizational skills
  • Experience in IDE/Class III medical device clinical trials preferred
  • Knowledge of GCP, HIPPA, and Other Global Reporting Requirements
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)

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