Cordis · 5 months ago
Senior Field Specialist, Clinical Research (Remote/National Travel)
Cordis is a company specializing in the development of advanced drug device combination products for treating coronary and peripheral artery disease. They are seeking a Senior Field Specialist in Clinical Research to provide case support to physicians, ensure effective use of devices, and assist in the management of clinical studies.
Health CareHealth DiagnosticsMedical
Responsibilities
Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device
Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms
Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities
Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators
Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators interests and capabilities
Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team
Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues
Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams
Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies
Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team
Assist with oversight of activities performed by CRO
Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts
Reside within designated geographic territory to facilitate on-site visits to assigned clinical sites
Be available to cross-cover sites as back up for other CFS territories, including holding necessary credentialing
Attend and lead SIV and site activation activities at assigned sites (in-person priority) for duration of the event
Attend start-up phase enrollments and clinical follow up visits at each assigned site to ensure site protocol compliance, image upload and readability and quality data collection
Prioritize regular communication with study management team and CRO
Qualification
Required
Bachelor's Degree in life sciences, nursing, engineering, or healthcare related field
Minimum 3 years' experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or Cath lab tech
Minimum 3 years' experience working directly with physicians and healthcare professionals
Experience in coronary or peripheral interventions
Ability to travel (at least 75%) to company and clinical trial sites
Preferred
Prior experience with clinical trials
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
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