Clinical Trial Associate, Selution

1 week ago

Irvine, California, United States Cordis Full time $90,000 - $120,000 per year
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

We are seeking a Clinical Trial Associate to join our clinical study team in the peripheral/coronary space to help 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 MedAlliance, 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.

Key Accountabilities

Support study sites and activities to ensure adherence to appropriate industry US and OUS regulations, compliance with the study Protocol(s), and applicable local regulationsAssist in coordination of study tasks from start-up phase through study completionMaintain internal Trial Master Files (TMFs) and prepare study TMF for audit readinessAssist in organizing Steering Committee events and meetingsPrepare dashboards, reports and other internal tracking mechanismsWork with the CRO and Core Labs to ensure study operations and activities are of a high qualityAssist with organization and preparation for Investigator meetings and Study Coordinator meetingsEnsure proper escalation of site/project related issues to the Study Lead in a timely mannerVerify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staffAssist with device accountabilitySupport internal audit preparationCollect and file site study documentation (e.g. ICFs, CTAs, budgets)Qualifications

Required:A minimum of a Bachelor's degree.At least 1-2 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

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