Lead CRA / Principal CRA

ICON plc • Blue Bell, SD

1d • Onsite

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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.

Requirements

• Minimum education: Completion of a bachelor’s degree (scientific or clinical field) is required.
• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• An advanced degree is preferred.
• Experience supporting site and/or sponsor inspections is preferred.
• Experience auditing sites and TMF are preferred.

Responsibilities

• 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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior