Clinical Study Administrator

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

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities
from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

You will be doing:

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Recognize, exemplify and adhere to ICON's values which center on excellence in execution, exceeding expectations, and enhancing relationships
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  Travel (approximately 10%) domestic and/or international
  possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable)
• assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
• assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
• share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times
•  facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate
•  assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
   run, review and analyse study reports for accuracy and work with the project teams to ensure updates are completed correctly
• assist in coordination of study related payments, if applicable contact and serve as a contact for clinical sites for basic requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.)assist in the tracking and distribution of safety reports
• coordinate document translation, if required
• assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas
• assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
• assist with the coordination of various tracking reports, including but not limited to, team member tracking and training
  work in collaboration with internal and external colleagues to meet project objectives and timelines
• Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention
• maintain client and patient confidentiality
  
  

Requirements
• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

• Previous administrative experience preferably in the medical/ life science field.

• Proven organizational and administrative skills.

• Computer proficiency.

• Good knowledge of spoken and written English.

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, inclusion & belonging are fundamental to our culture and values.   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.