Clinical Research Associate - Single Sponsor

Clinical Research Associate - Single Sponsor

• Location: London

Reference: 48

• Categories: Clinical Monitoring
• Business Area: ICON Strategic Solutions
• Remote Working: Remote

About the role

As a Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
• Monitor those sites 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.
• Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.

Job Description:

• Recognize, exemplify, and adhere to ICON's values which centre on our commitment to People, Clients, and Performance.
• 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'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:
• Identify investigators.
• Assist in the preparation of regulatory submissions when requested.
• Design patient information sheets and consent forms.
• Ensure timely submission of protocol/consent documents for ethics/IRB approval.
• 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 to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and diligent accounting 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.
• Ensure proper management of investigational products (IPs) stored 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 complies with regulatory requirements and is in accordance with the sponsor.
• Act in a lead role on a study assuming additional responsibilities as documented by the Project Manager if appropriate.
• Participate in data listing reviews, as applicable.
• 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.

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 maximize 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 specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON:

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates.

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.

Impactful work. Meaningful careers. Quality rewards.

At ICON, our employees are our greatest strength. That's why we are committed to empowering you to live your best life, both inside and outside of work.