Sr Field Clinical Rsrch Specialist

Medtronic Inc. Raleigh , NC 27611

Posted 1 week ago

This is a field-based position.

Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

Field-based position responsible for clinical trial site management, case coverage and clinical trial data tracking.

The C-RDN (Coronary-Renal Denervation) Field Team works closely with study sites to conduct Medtronic coronary and renal denervation clinical studies designed to alleviate pain, restore health and extend the lives of patients.

Come for a job, stay for a career.

CVG

Cardiac and Vascular Group (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. This group includes Aortic, Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.

Within CVG, the Coronary and Structural Heart (CSH) 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

Responsibilities may include the following and other duties may be assigned.

  • Provides field support for various clinical research studies by selecting sites, performing activation duties, setting up protocols, providing training, helping to enroll participants, ensuring quality data acquisition and performing study closure activities.

  • Responsible for gaining and maintaining knowledge of clinical sites in a given geographic area to best understand and assess investigators' interests and capabilities.

  • Provides continuous communication to in-house clinical trial leaders regarding the status and performance of multiple studies.

Other Responsibilities:

  • 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 meet trial inclusion/exclusion criteria.

  • 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).

  • May provide work direction to Project Coordinator(s) and Clinical Research Associate(s).

  • May provide work direction to Clinical Monitors to ensure compliance with the Clinical Investigation Plan and appropriate regulations, guidelines and policies.

  • Able to refer to Standard Operating Procedures (SOPs) and study management process for guidance on everyday study tasks.

  • Contribute to ongoing SOP development and review.

  • Participate in training to enhance knowledge base.

  • May be asked to cover other US Regions, as needed.


Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

  • Bachelor's degree with a minimum of 2 years of experience in clinical research within the healthcare industry (e.g., medical devices, hospital) or advanced degree with a minimum of and 0 years of clinical research experience within the healthcare industry (e.g., medical devices, hospital)

Nice to Have (Preferred Qualifications):

  • Degree in engineering, life sciences, or related medical/scientific field.

  • Field Clinical Research experience at Medtronic or within a medical device industry.

  • Hospital/Clinical experience

  • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology

  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.

  • Experience in managing clinical trial data review.

  • Ability to incorporate and adhere to good clinical practices and regulatory standards.

  • Ability to manage multiple clinical research sites with proven results in study execution.

  • Ability to identify and implement solutions in addressing study issues.

  • Basic understanding of biostatistics and trial design.

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 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)

Ability to travel 50-75%.


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Sr Field Clinical Rsrch Specialist

Medtronic Inc.