IHCRA

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

This role is responsible for comprehensive trial and site administration. Under the oversight of the Start Up Lead, the person prepares, collates, distributes and archives clinical documents.
The CTA / IH CRA supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. 

What you will be doing:

• Trial and site administration
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country
    roles
  • Manage Labeling requirements and coordinate/sign translation change request
• Document management
  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF
  • Assist with eTMF reconciliation
  • Execute eTMF Quality Control Plan
  • Update manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Obtain translations of documents
• Regulatory & Site Start-Up responsibilities
  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments
  • Develop, control, update and close-out country and site budgets (including Split site budget)
  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
  • Track and report contract negotiations
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Calculate and execute payments (to investigators, vendors, grants)
  • Ensure adherence to financial and compliance procedures
  • Monitor and track adherence and disclosures,
  • Maintain tracking tools
• Meeting Planning
  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

You are:

• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions

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, 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 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.