Job Description

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 Senior Clinical Research Associate (Coronary) role is a key position within the coronary program to help ensure FDA clearance through a PMA approval of this innovative device is granted and patients have access to this device.

In this role, you will be participating in a clinical study team in the coronary space to execute a randomized, multi-center IDE clinical trial. You will perform various duties and responsibilities as directed by the clinical study leader. This research is the top priority for Selution, giving you the opportunity to be directly involved in the success of the organization in improving patient care. In this role, you will assist in organizing and monitoring the different stages of clinical trials. You will interact with healthcare professionals and with internal project teams.

Responsibilities

• Supervise study sites and activities to ensure adherence to appropriate US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations
• Manage and maintain internal Trial Master Files (TMFs). Potentially develop a standardized eTMF file nomenclature so that all files are consistently named
• Assist in organizing Steering Committee events and meetings, along with helping to prepare educational content
• Prepare dashboards, reports and other internal tracking mechanisms
• Work with the CRO and Core Labs to ensure study operations and activities are of a high quality
• Assist with organization and content preparation for Investigator meetings and Study Coordinator meetings
• Ensure proper escalation of site/project related issues to the Study Lead in a timely manner
• Assist with internal audit preparation
• Provide and communicate detailed reviews of site study documentation (e.g. ICFs, CTAs, budgets) to managers and study sites
• Study eTMF audit readiness
• Site management

Qualifications

• Bachelor's degree, required
• At least 5-7 years of experience working in the medical device space in a CRO or Sponsor setting with strong knowledge of conducting studies under ICH and GCP guidelines

Job Tags

Full time, Local area,

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