CRA II
- South Korea
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
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As a (Clinical Research Associate II, Senior CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Conduct of clinical research activities independently in accordance to ICH GCP and SOP’s.
- Investigator identification and selection
- Investigator Meeting activities
- Design and review of study material, such as patient information sheets, consent forms, monitoring plans etc
- Timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements
- Site visits, including Pre study, initiation, monitoring and close out visits
- Maintain all files and documentation pertaining to the studies
- Complete accurate study status reports
- Ensure the correct storage & accountability of study materials and investigational product
- Process case record forms to the required quality standards and timeliness
- Deal with clinical generated queries in a timely manner
- Ensure correct archiving of files on completion of a study
- Maintain patient and sponsor confidentiality
- Co-ordinate and/or participate in feasibility studies for new proposals, as required
- Act in a lead role on a study, assuming additional responsibilities as detailed/documented by the PM, if appropriate
- Project coordination, planning and logistics, including overview of budget and timelines
- Effective Communication:
- Maintain professionalism at all times
- Keep the project manager or designees regularly informed
- Motivate investigators in order to achieve recruitment targets
- Present at meetings as required.
- Recognize, exemplify and adhere to Company’ values which center around our commitment to People, Clients and Performance.
- Ability and willingness to travel as and when required by the company.
- Participate in training and mentoring new staff up to Clinical Research Associate level as required
#LI-remote
#LI-SO1
You are:
- Degree or Masters in Life Science, Nursing or Health Related
- +2 years experience as a CRA and special knowledge in a therapeutic area (CV)
- Strong knowledge of ICH-GCP and a strong interest in clinical research
- Professional use of the English language; both written and oral
- Hold global studies experience
- Home-based
- Indication: CV
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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