Insight Global is looking for a Clinical Research Associate to support one of our Fortune-500 Medical Device clients. The purpose of this position is to provide study monitoring for clinical studies conducted by the Urology Critical Care (UCC) business unit. The studies range from simulated use studies to complex studies that may include devices or drug/device combinations. The Clinical Research Associate serves as a study monitor for moderate to complex studies in compliance with Good Clinical Practices. A key focus of this role is overseeing site operations and proactively resolving any issues that arise during the course of the study. The Clinical Research Associate role encompasses responsibilities across both data management and on-site study oversight. This remote role includes regular travelup to 50%for site visits, check-ins, and related responsibilities. When not traveling, the position will be performed from a home-based office.
Responsibilities:
Author study-specific Monitoring Plan aligned with clinical investigational plan
Prepare, Contribute, Review and/or maintain study specific documentation and training materials
Possess a working knowledge of the disease state and product(s) under investigation
Effectively train and manage clinical study sites ensuring compliance with regulatory requirements and standards
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3-10 years of experience as a field-based Clinical Research Associate in the medical device/pharmaceutical industry
Strong site management and data monitoring experience
Technical proficiency in Veeva eTMF (Data Management System)
Ability to work and operate independently
Willingness and ability to travel up to 50% of the time for business-related site visits and responsibilities
Bachelor's Degree in healthcare or science related field
Previous experience or familiarity with the Urology and Critical Care therapeutic area
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.