Lead CRA / Principal CRA

🔥 19 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate study milestones • Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks • Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness • Execute remote or on-site site qualification and facilitate site selection • Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials • Review and approve FSP CRA Monitoring Visit Reports • Review site and monitoring Key Risk Indicator metrics and contribute to the Study and Site Risk Assessment Tool • Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents • Perform site management and act as an escalation point for FSP CRA monitoring quality issues • Develop or ensure implementation of site CAPA Plans and escalate issues as needed • Ensure sites are inspection-ready and support the sponsor during site inspections • Utilize CTMS and TMF to file documents, maintain accurate site data, and audit site TMFs as needed • Draft, review, or contribute to Site Monitoring Plans • Contribute to monitoring process improvement initiatives, SOPs, work instructions, job aids, and tools • Improve site selection, monitoring, and monitoring oversight templates in Veeva CTMS and EDC • Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs

🎯 Requirements

• 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 is preferred • Legal right to work in the country where the role is based

🏖️ 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