Senior CRA - Oncology focus

Overview

As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This role is focused on Oncology studies within a Biotechnology sponsor. Please note that we are looking for strong CRA's with 3-4 years of prior experience.This role will be travelling across Ireland.

Responsibilities

Senior CRA - Oncology Focused.

• Recognize, exemplify and adhere to ICONs values which centre on our commitment to People, Clients and Performance.

• 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.
• Ability and willingness to travel
• Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
• Familiarity with ICON systems
• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Recruitment of investigators.
• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:

• Identify investigators.
• Help when requested, in preparation of regulatory submissions.
• Design of patient information sheets and consent forms.
• Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON
• site monitoring SOP/sponsor site monitoring SOP, as appropriate
• Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the Project Manager regularly informed.
• Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.
• Ensure the satisfactory closeout of investigator sites.
• Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.

• Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study.
• Maintain patient and sponsor confidentiality.
• Assume additional responsibilities as directed by the Project Manager.
• investigational Products (IPs) stored and managed by the site:

o Ensure storage conditions and acceptable supplies are provided

o Ensure IPs are supplied only to eligible patients o Ensure IP receipt, use and return are controlled and documented

o Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

o Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate

• • Participate in data listing reviews, as applicable.
  • Responsible for cost effectiveness
  • Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate. • Assist with marketing the company if and when appropriate.
  • Other duties as assigned.

Qualifications

You are:

• 3-4 years if independent monitoring experience desired 
• Previous Oncology experience 
• Ability to travel across Ireland

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 othe