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Clinical Case Support Specialist
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-01-27
Listing for:
Concept Medical Inc.
Full Time
position Listed on 2026-01-27
Job specializations:
-
Healthcare
Clinical Research, Medical Science
Job Description & How to Apply Below
- 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.
- 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.
- 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.
- Strong situational awareness in cath lab environment.
- Attention to detail, documentation accuracy, and compliance mindset.
- Ability to travel to investigational sites across the US as required (up to 60%).
- Team‑oriented, adaptable, and calm under procedural pressure.
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