Clinical Case Support Specialist

Concept Medical is seeking an experienced Clinical Case Support Specialist to provide on-site and remote clinical trial support for IDE studies of a sirolimus-coated balloon in the cardiovascular domain. The role supports protocol adherence, subject safety, clinical case procedures, training, documentation, and coordination among investigational sites, sponsor teams, and CRO partners.

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

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

Interventional Cardiology Studies

Peripheral Artery Disease Studies

Device Studies

Drug-Device Combination Products

Clinical Specialist Experience

Field Clinical Engineering

Cardiovascular Studies

Communication

Presentation

Physician Engagement

Clinical Team Engagement

Company

Interventional medical devices for cardiovascular and peripheral care.

Surat, Gujarat, IND

https://www.conceptmedical.com/

Founded in 2008

201-500 employees

Qualifications

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

Strong situational awareness in cath lab environment

Attention to detail, documentation accuracy, and compliance mindset

Team-oriented, adaptable, and calm under procedural pressure

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

Minimum 2–5 years of experience in clinical research, cath lab, or cardiovascular device and Clinical trials.

Required skills

Angioplasty, Cardiovascular Device Trials, Clinical Research, Clinical Trial Documentation, Drug-Coated Balloon Interventions, EU MDR, FDA Investigational Device Exemption (IDE), ICH-GCP E6(R2), Informed Consent Processes, Source Data Verification, Stent Interventions

Preferred skills

$60.6M, 2011-08-18, 2018-10-09, 2026-04-27, 2026-04-29, 2026-09-21, AI Tools, Analyze How Well You Fit, Build Cover Letter, Canada NewsWire, Company data provided by, Customize Your Resume, Debt Financing, Dr Kiran C Patel, Growth Stage, Key Investors, Make your application stand out, Maximize your interview chances, PR Newswire, Recent News, SEC Filings, Seed· $0.6M, Series Unknown· $60M, Surat, Gujarat, IND, Total Funding, UNITED STATES SECURITIES AND EXCHANGE COMMISSION, Understand your strength & weakness, https://www.conceptmedical.com/

Experience

2-5 years