The Lead Clinical Research Associate (LCRA) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on our clinical trials. The LCRA is the key representative for clinical monitoring on the Study Team and under the direction of the Clinical Operations Study Lead (COSL), they provide leadership and direction to their assigned CRAs throughout the lifecycle of a study.  The LCRA assesses clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the COSL and Clinical Monitoring management team. The Lead CRA ensures the monitoring activities of their assigned study(s) are in accordance with sponsor policies and procedures, ICH/GCP and local regulations. The LCRA will report directly to the Associate Director, Clinical Monitoring.

What you will be doing:

• The Lead CRA is responsible for the leadership of their assigned CRAs on a given study(s), driving the team to ensure study deliverables are met with efficiency and quality
• Develops or contributes to the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials
• Responsible for training the CRAs on the study and ensuring study training compliance is maintained
• Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc…) to ensure the CRAs are informed and managing their site’s data with quality and integrity
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Conducts regular meetings with their CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
• Works with the Clinical Monitoring management team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery

You are:

• Bachelors or equivalent degree preferred, preferably in life sciences, medicine or related discipline
• Minimum of 5 years Clinical Research experience, with at least 3 years of experience in clinical site monitoring
• Ability to travel up to 30% of the time
• Fundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCP
• Strong knowledge of clinical trial systems, e.g. electronic case report forms, electronic Trial Master File, and Clinical Trial Management System
• Excellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environment
• Proven effectiveness as a team leader
• Outstanding interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity
• Demonstration of successful execution of programs in a fast-paced environment managing multiple priorities

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, 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 organisation. 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, color, 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.