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Clinical Research Specialist

Irvine, CA 92604
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Clinical Research Specialist


Irvine, California, United States

Requisition #:


Post Date:

Mar 23, 2020

**Careers thatChange 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 researchstudies.

+ Prepares and authors protocolsand patient record forms.

+ Conducts registered andnon-registered clinical studies of products that have been determined tosatisfy a medical need and/or offer a commercial potential.

+ Oversees and interpret resultsof clinical investigations in preparation for new drug device or consumerapplication.

+ Oversees and resolvesoperational aspects of clinical trials in conjunction with project teamsand in accordance with standard operating procedures (SOP), good clinicalpractice (GCP) and specific country regulations and may prepare clinicaltrial budgets.

+ May be responsible for clinicalsupply operations, site and vendor selection.

**Must Have (Minimum Requirements):**

+ Bachelor's Degree with a minimumof 2 years of clinical research experience, or advanced degree with 0 years of clinical researchexperience

**Nice to Have**

+ Proficient knowledge ofclinical research terminology

+ Experience working on medical device trials

+ Experience working novel datasources

+ 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

+ Capableof 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 ontime deliverables

+ Excellent oral and written communications

+ Effective interpersonal skills with the ability to influence andlead 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. Lets 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)
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.


Posted: 2020-03-26 Expires: 2020-05-03
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Clinical Research Specialist

Irvine, CA 92604

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