Senior CRA

Home-Based, Senior CRA (Oncology), South Korea

As a (Senior CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

A Senior Clinical Research Associate has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement. A SCRA may be assigned lead activities and more complex trials that utilizes the experience and autonomy.

• 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 DOCS’ 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
• Assist with marketing the company if and when appropriate

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You are:

• Degree, Masters or PhD in Life Science, Nursing or Health Related
• +4 years experience as a CRA and special knowledge in a therapeutic area-Oncology
• Strong knowledge of ICH-GCP and a strong interest in clinical research
• Professional use of the English language; both written and oral
• Home-Based

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.