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Job Description

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

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

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 null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].