Lead Clinical Research Associate - Oncology - US

Position:

We are seeking a highly experienced, collaborative, and detail-oriented Lead CRA capable of helping our client optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development.

The successful candidate will work closely with the sponsor's Site Engagement and Monitoring Excellence (SEME) team, global Functional Service Provider (FSP) Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.

About You:

You have significant monitoring experience and a passion for training and mentoring other CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to execute monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites. You are able to successfully develop and maintain positive site relationships in parallel with ensuring optimal trial conduct and quality with our client's clinical trial sites within your territory.

What You'll Do:

• Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate the progress of study milestones such as enrollment and major study milestones.
• Promote awareness of sponsor's clinical pipeline and programs to trial sites, investigators, and networks.
• Conduct Monitoring Oversight Visits on behalf of sponsor to assess FSP CRA monitoring quality and site inspection readiness.
• Execute remote or on-site qualification of sites for sponsor trials as needed, and promptly facilitate site selection.
• Schedule and conduct Site Initiation, Interim Monitoring and Close-Out visits as needed to co-monitor, train and/or onboard FSP CRAs across oncology trials. On-site visits are preferred at sponsor.
• Review and approve FSP CRA Monitoring Visit Reports.
• Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution across regional territory. Contribute to developing the Study and Site Risk Assessment Tool.
• Train and re-train FSP CRAs and sites on GCP, the protocol, vendor processes and study-specific documents.
• Perform consistent site management and act as an escalation point for FSP CRAs to resolve monitoring quality issues; develop/ensure implementation of site Corrective and Preventive Action (CAPA) Plans and escalate as needed.
• Ensure sites are inspection-ready and support the sponsor during site inspections.
• Effectively utilize the CTMS and Trial Master File (TMF) to ensure that SEME and site documents are promptly filed and site data is accurate; audit the site TMFs as needed.
• Independently draft, review or contribute to the development of a Site Monitoring Plan as needed.
• Contribute to monitoring process improvement initiatives by reviewing and/or developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS and the EDC by identifying gaps, suggesting updates, testing and implementing change controls as needed.
• Establish and foster effective relationships with internal and external stakeholders, such as investigators, site staff, sponsor study team members and FSP CRAs.

Qualifications/Requirements

• Minimum education: Completion of a bachelor's degree (scientific or clinical field) is required. An advanced degree is preferred.
• 8+ years monitoring Oncology (solid tumor) trials (with a minimum of 4 years monitoring phase I and/or Phase III Oncology) is required.
• Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required.
• Experience utilizing Veeva CTMS and TMF is required.
• Experience supporting site and/or sponsor inspections is preferred.
• Experience auditing sites and TMF are preferred.

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, LifeWorks, 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 site to read more about the benefits ICON offers.

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.

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