Clinical Research Specialist - Santa Rosa , CA | Biospace
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Clinical Research Specialist

Medtronic

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Location:
Santa Rosa , CA
Posted Date:
8/25/2017
Position Type:
Full time
Job Code:
140730
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

MAIN PURPOSE OF JOB
The Clinical Research Specialist will collaborate with Clinical leadership to support PMA strategy and submission activities, cross-functional business initiatives, External Research Programs, and future clinical study management. This position will be responsible for managing and meeting the objectives of a clinical study or clinical program and will play a key role in the fast-growing endoVenous and Embolization business at Medtronic.

**Please note, this position is located in Santa Rosa, California, and not a remote opportunity.

Requisition 17000F4E
https://jobs.medtronic.com/jobs/search/29721410   

Requirements

MAIN JOB DUTIES/RESPONSIBILITIES  
Performs the following tasks with general direction:
•   Assists in preparing study strategy, scope and schedule in order to meet business needs;
•   Assists in the development, design, and execution of clinical studies;
•   Assists in the preparation of clinical PMA submission documents and strategy;
•   Reviews cross-functional marketing collateral for accuracy and messaging;
•   Assists in the management of External Research Programs;
•   Develops and maintains a high level of medical, technical and clinical expertise through relevant literature, scientific meetings, and interaction with various inside/outside experts;
•   Ensures compliance with regulatory directives / guidelines and the Clinical Investigation Plan;
•   Plans and coordinates project activities to ensure timely completion of the investigation;
•   Reports on progress and results of clinical investigations;
•   Interprets, evaluates and analyzes clinical data, provides interim / final reports;
•   Collaborates closely with key opinion leaders;
•   Partners with cross-functional project teams, e.g. R&D, Regulatory Affairs, Marketing and Sales

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BASIC QUALIFICATIONS:
•   Bachelors degree. Masters degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
•   2+ years experience directly supporting clinical research or similar experience in a medical/scientific area.


COMPETENCIES
•   Global perspective
•   Customer focus
•   Demonstrated ability to work effectively on cross-functional and international teams
•   Effective communication (advanced written and oral communications skills)
•   Technical writing
•   Able to manage multiple tasks
•   Results and quality oriented
•   Experience with GCPs and regulatory compliance guidelines for clinical trials
•   Understanding of biostatistics and trial design


MEDTRONIC OVERVIEW:
Together, we can change healthcare worldwide.  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 this an exciting and rewarding place to be.
We can 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.

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
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.