Cordis
Overview:
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. Responsibilities: The
Manager Clinical Field Research Specialist
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.
Job Functions: Manage and build a world class CFS team Ensure case coverage by utilizing site assignments and triaging case support Ensure processes and procedures that protect the quality of our clinical studies 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
Qualifications: Job Functions: Manage and build a world class CFS team Ensure case coverage by utilizing site assignments and triaging case support Ensure processes and procedures that protect the quality of our clinical studies 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
Role Expectations: Build and manage a world class team 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
Qualifications Bachelors Degree in a life science, nursing, engineering, or healthcare related field (preferred) Minimum 8 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 8 years experience working directly with physicians and healthcare professionals Prior experience with clinical trials (preferred) Experience in coronary or peripheral interventions Experience with Good Clinical Practice (GDP) and/or regulatory compliance guidelines for clinical studies Ability to travel (at least 75%) to company and clinical trial sites
Preferred Qualifications: Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one?s identity. All our teammate?s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. Preferred Qualifications 1: Pay / Compensation The expected pre-tax pay rate for this position is $111,650 - $159,500 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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. Responsibilities: The
Manager Clinical Field Research Specialist
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.
Job Functions: Manage and build a world class CFS team Ensure case coverage by utilizing site assignments and triaging case support Ensure processes and procedures that protect the quality of our clinical studies 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
Qualifications: Job Functions: Manage and build a world class CFS team Ensure case coverage by utilizing site assignments and triaging case support Ensure processes and procedures that protect the quality of our clinical studies 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
Role Expectations: Build and manage a world class team 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
Qualifications Bachelors Degree in a life science, nursing, engineering, or healthcare related field (preferred) Minimum 8 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 8 years experience working directly with physicians and healthcare professionals Prior experience with clinical trials (preferred) Experience in coronary or peripheral interventions Experience with Good Clinical Practice (GDP) and/or regulatory compliance guidelines for clinical studies Ability to travel (at least 75%) to company and clinical trial sites
Preferred Qualifications: Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one?s identity. All our teammate?s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. Preferred Qualifications 1: Pay / Compensation The expected pre-tax pay rate for this position is $111,650 - $159,500 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.