ICON Strategic Solutions · 4 hours ago
Senior Clinical Research Associate, Remote, Midwest Region
United States
Full-time
Remote
Senior Level
5+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are currently seeking a Senior Clinical Research Associate (CRA) in the Midwest Region to oversee and manage clinical trial activities, ensuring compliance with protocols and regulatory requirements. The role involves site management, monitoring activities, and supporting sites throughout the study lifecycle.
Pharmaceuticals
Responsibilities
Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites
Perform 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 trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities and submit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
Support sites during regulatory inspections
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Qualification
Required
Bachelor's degree (scientific field preferred)
5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
Experience utilizing Veeva CTMS for report writing is required
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Willing to travel up to 50% domestically
Reside in Midwest Region USA
Preferred
1+ years early development trial experience preferred
Solid tumor clinical trial experience is preferred
Experience working within an FSP (or in-house) monitoring model is preferred
Benefits
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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