Clinical Case Support Specialist jobs in United States
cer-icon
Apply on Employer Site
company-logo

Concept Medical · 1 day ago

Clinical Case Support Specialist

positionNew York, United States
timeFull-time
remoteHybrid
seniorityEntry, Mid Level
date2+ years exp

Concept Medical is seeking an experienced Clinical Case Support Specialist to provide clinical trial support for IDE studies involving a Sirolimus-Coated Balloon in the cardiovascular domain. This role is essential for ensuring protocol adherence, subject safety, and data integrity during case procedures while facilitating communication among investigational sites, sponsor teams, and CRO partners.

Health CareMedicalMedical Device

Responsibilities

Provide on-site or on-line procedure support during investigational DCB angioplasty cases, ensuring adherence to study protocol, device handling SOPs, and ICH-GCP requirements
Act as the technical and clinical liaison between investigators, cath lab teams, and sponsor during case execution
Support subject eligibility verification, informed consent review, and device accountability in compliance with 21 CFR Part 812 and ISO 14155 standards
Document case-related observations, protocol deviations- if any, and procedural data in accordance with the monitoring plan
Assist in site initiation, training, and qualification activities related to IDE protocol
Maintain real-time records of procedural outcomes, adverse events, and device usage logs
Support CRA/monitoring teams with source data verification (SDV) and query resolution
Ensure compliance with regulatory, ethical, and sponsor-specific quality standards
Work closely with R&D, Regulatory Affairs, and Clinical Project Management to provide field feedback and procedural insights
Participate in risk assessments, monitoring reviews, and data quality meetings
Provide training or refresher sessions to cath lab staff on investigational device handling, use of the Investigational device and Trial Protocol as needed

Qualification

Clinical trial supportAngioplasty experienceRegulatory complianceClinical documentationInterventional cardiologyCommunication skillsAttention to detailTeam-oriented

Required

Bachelor's degree in Nursing, Biomedical Engineering, Life Sciences, or equivalent clinical field
Minimum 2–5 years of experience in clinical research, cath lab, or cardiovascular device and Clinical trials
Hands-on experience with angioplasty, stent, or drug-coated balloon interventions in CAD and PAD space
Familiarity with FDA IDE, ICH-GCP E6(R2), and EU MDR or other regional regulatory frameworks
Strong understanding of clinical trial documentation, source data verification, and informed consent processes

Preferred

Experience supporting interventional cardiology (CAD) and Peripheral artery disease (PAD) device studies or drug-device combination products
Prior role as clinical specialist, field clinical engineer, Cath lab nurse/technician, or clinical research associate in cardiovascular studies
Excellent communication and presentation skills with the ability to engage physicians and clinical teams

Company

Concept Medical

twittertwittertwitter
company-logo
Concept Medical is Developing Innovative Medical Devices for the Treatment of Coronary Artery Diseases & Peripheral Artery Disease.
dateFounded in 2008
location
Tampa, Florida, USA
people-size201-500 employees
web-link
https://www.conceptmedical.com/

Funding

Current Stage
Growth Stage
Total Funding
$60M
Key Investors
Dr Kiran C Patel
2018-10-09Series Unknown· $60M

Recent News

thecanadianpressnews.ca
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
2025-08-04
EIN Presswire
Angioplasty Balloons Market anticipated to surpass US$3.602 billion by 2030 at a CAGR of 4.91%
2025-06-30
Canada NewsWire
Fondazione Ricerca e Innovazione Cardiovascolare Completes Enrollment in TRANSFORM II RCT, A landmark study comparing MagicTouch SCB vs DES in Native Coronary Vessels
2025-06-13
Company data provided by crunchbase