Senior Field Specialist, Clinical Research (Remote/National Travel)

Cordis•Irvine, CA

32d•$76,450 - $125,000•Remote

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. The Field Specialist, Clinical Research position that provides case support to physicians within a given territory. Case support provided on peripheral and coronary interventional procedures in pre-market and post-market phases of product development with SELUTION-SLR. The CFS plays a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs.

Requirements

Ability to travel 75%+ within designated geographic territory
Bachelor’s Degree in life sciences, nursing, engineering, or healthcare related field (preferred)
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
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Nice To Haves

Prior experience with clinical trials (preferred)

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
Ability to travel 75%+ 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