Senior CRA Posted Date 28 minutes ago(1/3/2025 8:58 AM) ID 2024-115830 Location : Location US-Remote Overview

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites in the United States (US). We are looking for someone located in the NE, SE or Southern US.

Responsibilities

What you will be doing:

Perform site management activities to support Oncology site success and maintain a continuous state of inspection readinessAct as the primary contact and facilitate efficient communications between the clinical trial team and the sitesPerform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trialsMay perform oversight activities to assess monitoring quality and train/mentor less experienced CRAsPromptly document monitoring activities and submit/approve visit reportsManage site essential document collection and TMF reconciliation with site filesSupport sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvalsRegularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolutionIndependently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plansDeliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulationsSupport sites during regulatory inspectionsContribute to site identification; drive site feasibility and qualification progress; and support site activation activitiesLead site engagement initiatives and foster relationships with key Oncology sites and networks Qualifications

You are:

 

Bachelor’s degree (scientific field preferred)5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits1+ years early development trial experienceSolid tumor clinical trial experience is preferredExperience utilizing Veeva systems is preferredDemonstrated experience developing/maintaining site relationships and securing complianceExpertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminologyExperience collaborating with sites from initial engagement through close-out phasesExperience activating sitesExperience training site staffExperience supporting sites and/or sponsors in regulatory inspectionsExperience working within an FSP (or in-house) monitoring model is preferredWilling to travel up to 50%

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 entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal 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-beingLife assuranceFlexible 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.

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