Clinical Research Associate II (Telecommute/ Contract)

The Clinical Research Associate II(CRA II) performs routine site visits to ensure that the rights and well-being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines and other applicable regulatory requirements. In doing this, the CRA representsOptuminsightand the sponsor to site personnel and colleagues with professionalism and integrity.

Responsibilities

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
  
• 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 eClinical or alternative 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).
  
• Perform other duties as assigned.

 RequirementsRequirements:

• Bachelors level degree in life sciences, pharmacy, nursing or RN required
  
• Two to five 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 approximately 60% travel (may be up to 80% during peak times)

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, youll be empowered to ask more questions, develop better solutions and help make the health care system greater than ever. Its always fresh. Its always exciting. And its never been more important.

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.

Country: USA, State: Colorado, City: Denver, Company: UnitedHealth Group.
jobs?state=Colorado" target="blank">View more jobs in Colorado