CRA I

As a CRA 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. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs, applicable regulations and the principles of ICH -GCP

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 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 60%) domestic and/or international.
• *Familiarity with 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.
• Familiarity with principles of investigator recruitment.
• *Assist with coordinating all the necessary activities required • *Assist with coordinating 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.
Coordinate 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/WP 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 close-out of investigator sites. Ensure correct archiving of files on completion of a study.
Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits. Participate in feasibility studies for new proposals, as required
Maintain patient and sponsor confidentiality .
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.
• To 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 data listing reviews, as applicable.
• *To be cost effective.
• Ass ist with marketing the company if and when appropriate.
• Other duties as assigned.

The role:
As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.

You will need:
• University degree in medicine, science, or equivalent
• You should also have knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
• You will possess excellent written and verbal communication in English
• Good social skills enabling you to deal with queries in a timely manner
• You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid drivers license

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Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.