Clinical Research Associate II - US
- United States
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Specialist
- Icon Strategic Solutions
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
- Contribute to the identification of new sites for clinical trials
- Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial.
- During all phases of the trial ensure archiving per relevant SOP.
- Execute site initiation and training, generate initiation visit report.
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Complete preparation and generation of visit monitoring reports as per relevant SOP.
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection
- Improve skills by timely completion performance of assigned global and local training.
You are:
- Bachelor’s Degree or higher in life sciences or equivalent
- Minimum 3 years’ clinical site monitoring experience focused in oncology
- Comprehensive knowledge and understanding of ICH-GCP
- Able and willing to work on several protocols/therapy areas
- Experience in phase I-IV trials
- Working knowledge of Electronic Data Capture (preferred)
- Excellent attention to detail
- Highly developed time management and organizational skills
- Focused on meeting study deliverables/targets
- Flexible and willing to adapt to changing priorities/timelines
- Experience in oncology is required (Breast, lung and Hem/onc expereince preferred)
What ICON can offer you:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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