UnitedHealth Group is among the most ambitious Fortune 25 companies you'll ever meet. Through our family of businesses, we're working to make the health care system perform better for more people, in more ways than ever.
Simply put, we think the entire system can be greater than it's ever been. And that drives us to work harder, aim higher, and expect more from one another.
Here, you'll be empowered to make an immediate impact for millions of others. And you'll achieve more than you ever expected. How does that fit with your plans?
Clinical Research Associate II (Oncology experience required)-315347
UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.
Description i3 Research is a full-service, global CRO specializing in central nervous system, oncology, respiratory and infectious diseases, endocrinology and metabolic diseases, and cardiology. We approach our work with an intense focus on the unique demands of these therapeutic categories and the needs of our clients. We deliver the therapeutic science that helps our clients develop better patient care.
As a UnitedHealth Group company, i3 Research is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Research can provide.
The Clinical Research Associate (CRA) 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 represents i3 Research and 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 i3 Research 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.
Qualifications Qualifications
- Bachelor's level degree in life sciences, pharmacy, nursing or RN preferred
- 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)
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.
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. |
