Job: Clinical Research Associate II for OptumInsight

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Jobing Description

Position Description:


Positions in this function are responsible for visiting sites that are contracted for clinical studies to review information relevant to clinical trials. Reviews all necessary documents and ensures all data collected in the clinical research forms follows outlined procedures. Assesses the physical locations related to the trial to ensure protocols are adhered to. Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs these responsibilities with minimal support from management


Primary Responsibilities on Visits to include:

• Documents any violations or areas of concern


• Ensures reporting of adverse events


• Provides data to the Data Management function


• Monitoring of proper informed consent procedures


• Compliance with protocol


• GCP/ICH Guidelines and other applicable regulatory requirements


• Assurance of good site performance


• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements


• Report to OptumInsight project team, client, and site personnel any findings noted at monitoring visits


• This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines.


• Significant issues noted must be reported to appropriate personnel immediately


• Maintain project tracking system of subject and site information


• Participate in company-required training programs


• Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance)


• Maintain home office (e.g., procurement of office supplies, submission of documents), if applicable


• Perform other duties as assigned


• Analyzes and investigates


• Provides explanations and interpretations within area of expertise

This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.

OptumInsight is part of the family of companies that make UnitedHealth Group one of the leaders across most major segments of the US health care system.

OptumInsight is one of the largest and fastest growing health information companies. We specialize in improving the performance of the health system by providing analytics, technology and consulting services that enable better decisions and results. We integrate workflow solutions that deliver data in real-time, and create actionable insights - processing health information that relates directly to and affects one in four patients in the U.S, one in every three Medicaid dollars and one in every five emergency room visits. And we do it all with every action focused on our shared values of Integrity, Compassion, Relationships, Innovation & Performance.

What can YOU do with the right information? At OptumInsight, the possibilities and the impact are limitless. No matter what your role is at OptumInsight, you'll be empowered to ask more questions, develop better solutions and help make the health care system greater than ever. It's always fresh. It's always exciting. And it's never been more important.

Skills / Requirements

Qualifications:

• Bachelor's level degree in life sciences, pharmacy, nursing or RN preferred


• 2+ years clinical monitoring experience


• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements


• Ability to work independently in a fast-paced environment


• Strong communication, interpersonal, and organizational skills


• Must demonstrate good computer skills


• Position requires 70% - 80% travel is expected

Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/V

UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.