Sr Field Clinical Research Specialist (Nashville, TN) at Medtronic


Category
Manufacturing/Production/Operations
Company
Medtronic
Location
Tennessee, TN
Posted
11/20/2018
Description
Location: Nashville, TN
Careers that Change Lives
Impact patient outcomes. Come for a job, stay for a career.

CVG
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

A Day in the Life
Field-based position responsible for clinical trial site management, case coverage and enrollment activities.
Responsibilities may include the following and other duties may be assigned.
  • Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
  • Oversee preparation of and revisions to the Clinical Investigation Plan for assigned clinical studies.
  • Oversee preparation of study materials and/or training (e.g., training of investigators, site staff and Medtronic field staff).
  • Interface with, and assure training of investigators, site staff, and Medtronic clinical staff.
  • Assist in site initiation (e.g. oversight of start-up document preparation, distribution, receipt, and review).
  • Set-up and maintain accurate study status and implant logs.
  • Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical Groups).
  • Long term maintenance of study project plan.
  • Identify and mitigate quality risks and issues for assigned clinical studies.
  • May Oversee PR and enrollment activities at assigned sites by managing enrollment meetings and deliverables with various marketing teams.
  • May review and present cases for a screening committee to ensure study subjects meeting trial inclusion/exclusion.
  • May proctor or provide case support.
  • May arrange conference calls, staff meetings and training events. Assist in compilation and review of adverse event information.
  • Assist in coordinating field staff activities with clinical site needs.
  • Oversee follow-up and resolution of site issues noted by field staff.
  • Assist in compilation, review and conclusion of device complaints.
  • Oversee study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive).
  • Assist data management group with review of clinical data/information and oversight of data correction.
  • Assist in preparation of annual, interim and final reports and presentations.
  • Assist in control of device allocation, distribution and reconciliation.
  • Oversee activities performed by Contract Research Organizations (e.g. CROs, core labs).
  • Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base.

Qualifications
Must Have: Minimum Requirements
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING REQUIREMENTS MUST BE EVIDENT ON YOUR RESUME
  • Bachelor’s degree with a minimum of 4 years of clinical research experience (e.g., medical/scientific, industry/corporate, hospital/clinical or academic/university research) or advanced degree with 2 years or a Ph.D. or MD with 1 year of clinical research experience
  • Experience in clinical trial site management
Nice to Have
  • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
  • Experience in medical device
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Computer skills (MS Office products, word processing, spreadsheets, etc.)
  • High attention to detail and accuracy
  • Ability to manage multiple tasks
  • Good prioritization and organizational skills
  • Excellent problem-solving skills
  • Works effectively on cross-functional teams
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 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.
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.
Ability to travel up 50-75% of the time.
North America-United States-Tennessee