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 (CRA) - Hong Kong - Multiple locations
The Clinical Research Associate performs routine site visits to ensure that the rights and well‑being of human subjects are protected. Additionally, the Senior Clinical Research Associate assists in training and mentoring other regional monitoring personnel. In doing this, the Senior Clinical Research Associate represents i3 and the sponsor to site personnel and colleagues with professionalism and integrity.
i3 brings a sharp therapeutic focus to clinical research, while providing a global reach. With offices worldwide and capabilities in more than 54 countries, we have the resources to launch clinical trials all over the world. As a UnitedHealth Group company i3 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 can provide.
Main Responsibilities:
* Perform routine site visits, including pre-study, initiation, interim, and closeout visits. 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.
* 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.
* Serve as back-up for Regional Manager, Clinical Operations when required.
* Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.
* Participate in feasibility studies.
* Assist with company’s quality control initiative.
* Present study materials at Investigator/study launch meetings when required.
* Support project management team with assessment of workload and site assignments within the project team.
* Participate in the interview process of potential candidates when required.
* Participate in company-required training programs.
Qualifications/Requirements:
* Bachelor’s level degree in life sciences, pharmacy, nursing or RN preferred
* Demonstrated clinical monitoring experience
* Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Proven ability to work independently in a fast-paced environment
* Ability to provide clear direction and guidance to others.
* Position requires approximately 60% travel (up to 80% during peak times).
Benefits:
* A competitive remuneration package with excellent benefits including healthcare and pension.
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organisation.
* The opportunity to work within a successful and rewarding environment.
We look forward to receiving your application.
CRA / Clinical Research Associate / Senior Clinical Research Associate / Monitoring / CRO / Clinical Research Organisation / Pharma / Pharmaceutical / Clinical / Clinical Trials Manager / Clinical Monitor
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.
http://careers.unitedhealthgroup.com/
This job was posted 30+ days ago, and has expired.
