ICON Strategic Solutions · 5 hours ago
Senior CRA
United States
Full-time
Remote
Senior LevelICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. They are seeking a Senior Clinical Research Associate (CRA) with a strong focus on quality oversight to ensure high-quality execution at clinical trial sites and support compliance across oncology studies.
Pharmaceuticals
Responsibilities
Conducting quality oversight visits to assess site performance, compliance, and readiness for inspection
Performing co-monitoring visits and on-site quality assessments to ensure adherence to protocols, regulatory requirements, and GCP
Reviewing and supporting CAPA (Corrective and Preventive Action) development and resolution
Providing coaching and guidance to site teams to strengthen quality culture and ensure high-quality deliverables
Ensuring protocol compliance and identifying risks or issues that may impact study timelines or data integrity
Collaborating with cross-functional teams to support trial execution and communicate quality findings
Conducting training and providing guidance to site staff and CRAs as needed
Building strong, effective relationships with site personnel and stakeholders to support continuous improvement
Qualification
Required
Highly experienced CRA with a solid background in monitoring and site management; manager-level experience a plus
Strong quality mindset with demonstrated ability to identify issues, drive corrective actions, and support inspection readiness
Extensive understanding of clinical trial processes, GCP, and regulatory requirements
Proven ability to manage multiple priorities and work effectively within a small, agile, and nimble team
Expertise in monitoring practices, quality control, and data integrity
Excellent communication and interpersonal skills with the ability to influence and guide site personnel
Travel: Significant travel required (approximately 60–70%); valid driver's license required
Preferred
Advanced degree in life sciences, nursing, or a related field preferred
Oncology experience strongly 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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