Job Title Sr Clinical Research Specialist
Location: Irvine, CA, 92604, USA
Sr Clinical Research Specialist
Irvine, California, United States
Mar 16, 2018
outcomes. Come for a job, stay for a
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.
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
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.
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
A Day in the
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
Minimum of 4 years of relevant
experience, or advanced degree with a minimum of 2 years relevant experience
Is A Bachelors Degree
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
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
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.
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
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.
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.
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Website : http://www.medtronic.com/
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 Groups 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.