Field Clinical Research Specialist

at  Medtronic

CAREERS THAT CHANGE LIVES

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.
The Field Clinical Research Specialist is a field based, customer- facing position responsible for clinical trial site management, case coverage, and clinical trial data tracking.

MUST HAVE: MINIMUM REQUIREMENTS

• Bachelors degree required
• Minimum of 2 years of clinical research or medical/scientific experience, or advanced degree with 0 years of experience

PHYSICAL JOB REQUIREMENTS

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others)

• Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
• Assist with preparation of/revisions to the Clinical Investigation Plan for assigned clinical studies.
• Assist with the 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.
• Interface with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups).
• Identify and mitigate quality risks and issues for assigned clinical studies, with oversight from study management.
• May oversee PR (public relations) and enrollment activities at assigned sites by managing enrollment meetings and deliverables with various marketing teams.
• May review and present cases to a screening committee to ensure study subjects meeting trial inclusion/exclusion.
• Proctor or provide case support.
• Drive enrollment and data quality of clinical trials at the site level.
• 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).
• Interface with Customer for trial support.
• 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.
• Assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).
• 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