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Job Details

Sr Clinical Research Specialist

Company name
Medtronic, Inc.

Location
Irvine, CA

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Job Details

Company Medtronic

Job Title Sr Clinical Research Specialist

JobId 42000

Location: Irvine, CA, 92604, USA

Description

Sr Clinical Research Specialist

Location:

Irvine, California, United States

Requisition #:

******LH

Post Date:

Mar 16, 2018

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.

BRAIN

THERAPIES 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.

PAIN THERAPIES

offers solutions from early interventional procedures to implantable surgical

technologies that treat chronic pain as well as pain from spinal fractures,

cancer and severe spasticity.

SPECIALTY

THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal

disorders, conditions of the ear, nose and throat, as well as electrosurgical

products for soft tissue dissection and hemostatic sealing of soft tissue and

bone.

A Day in the

Life

Responsibilities may

include the following and other duties may be assigned.

Participatesin one or more clinical studies from preparation, activation, enrollment,submission, maintenance, and study closure phases.

Contributein the development and review of Clinical Investigational Plans withstatistical justifications, patient informed consent, case report forms,clinical study material, and clinical databases in collaboration with crossfunctional teams.

Ensurequality by maintaining compliance, reviewing device complaints, reviewing auditreports, and implementing corrective actions.

Manageinvestigative sites from study start up through close out.

Ensures appropriate oversight of clinical study by internal andexternal resources including, but not limited to monitoring, staff, CROs, andcore laboratories.

Coordinateclinical site audit activities including pre-inspection training at clinicalsites and within the department.

Ensurethe overall successful conduct of assigned clinical studies consistent withapplicable regulations, guidelines, and policies; e.g., monitoring reports,device tracking, and CAPA tracking systems.

Interactwith sites, vendors, and cross functional team member.

Contribute to protocol development includingliterature review, compilation of feedback from the cross functional team andkey opinion leaders, and drafting essential documents

Assist in the development and review ofClinical Investigational Plans with statistical justifications, patientinformed consent, case report forms, clinical study material, and clinicaldatabases in consultation with the cross-functional project team

Assist with investigation and site selectionprocess

Maintain CTMS and other project tracking tools

Lead the development of and update the studybudget

Maintain and update study records on ******************

Lead regulatory submissions including 510(k),PMA, IDE, and others

Lead the drafting and reviewing of studyreports

Perform the initiation and implementation ofclinical investigations

Review clinical monitoring reports

Evaluates clinical and adverse event data forcompleteness during the conduct of the study and for completion of clinicalstudy reports

Support the development and completion ofregulatory reporting requirements, internal reporting requirements, andclinical publications and presentations

Mentors junior team members on the executionof the project

Coordinate physician meetings such asInvestigator Meetings, Clinical Events Committees, and Data Safety MonitoringBoards

Performs related duties as assigned

Must Have:

Minimum Qualifications

Minimum of 4 years of relevant

experience, or advanced degree with a minimum of 2 years relevant experience

Is A Bachelors Degree

Required? Yes

Nice to Have

Excellentwritten, oral, and interpersonal communication skills

Resultsand solution oriented

Demonstratedability to make timely and well-reasoned decisions and adapt to shiftingpriorities and competing demands

Medicaldevice experience preferred

Ability to work independently and effectively on cross-functionalteams

Demonstrated ability to make timely and well-reasoned decisionsand adapt to shifting priorities and competing demands

Masters or Advanced Degree preferred

Medical device experience preferred

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.

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.

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:***************************************** 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.

Job Type

Permanent

Job Reference

1b143563f6a4df9

Job ID

19806972

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Company info

Medtronic, Inc.
Website : http://www.medtronic.com/

Company Profile
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.

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