Senior CRA

Overview

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

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP• Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

Responsibilities

Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.• As a member of staff, the employee I 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 at least 60% of the time (international and domestic: fly and drive)• *Expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.• *Expert knowledgeable of ICON systems.• *Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.• Recruitment of investigators.• *Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:Identify investigators.Help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.Co-ordinate documents translation, verification and back translations where required.Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.Pre Study/placement and initiation visits.Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriateMaintain 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 or designees 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 close-out 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.Ensure correct archiving of files on completion of a study. Maintain patient and sponsor confidentiality.Assume additional responsibilities as directed by Project Manager (PM)Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager.Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.Co-ordinate and/or participate in feasibility studies for new proposals, as required. lnvestigational Products (IPs) stored and managed by the site:• Ensure storage conditions and acceptable supplies are provided• Ensure IPs are supplied only to eligible patients• Ensure IP receipt, use and return are controlled and documented• Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.• *Be cost effective.• *Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.• Participate in data listing reviews, as applicable.• Assist with marketing the company if and when appropriate.• Other duties as assigned.

Qualifications

G-Bachelor's Level Degree

Minmum of 4 years experience in on-site monitoring in Clinical Research in CRO/ Pharma industry 

 

 

 

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 yo