Cra II
Not Disclosed•Full-TimeOn-site
location_onPlanifyr
About ICON
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence. Our mission is to shape the future of clinical development, and we welcome you to join us in this endeavor.
About the Role
As a Clinical Research Associate, you will serve as the primary point of contact between investigational sites and the sponsor. This role is critical to ensuring the integrity and quality of clinical trials across the southeast region. You will partner with cross-functional teams, including CTAs, LTMs, and CTMs, to support subject recruitment, monitor patient safety, and drive timely data entry.
The position requires a dynamic professional who thrives in a collaborative setting. You will be responsible for conducting various site visits, from selection and initiation to routine monitoring and close-out. Your day-to-day work involves ensuring site compliance with ICH-GCP and local regulations, managing drug accountability, and resolving data queries. This role offers the opportunity to work across multiple therapeutic areas while maintaining high standards of documentation and risk management.
We are looking for candidates residing in Utah near major HUB airports to support efficient regional travel, with a requirement to travel up to 50% for on-site monitoring visits.
Hiring Process
Interested in the role but unsure if you meet all of the requirements? We encourage you to apply regardless—there is every chance you are exactly what we are looking for. If you are a current ICON employee, please apply through the internal portal.
Equal Opportunity & Culture
At ICON, inclusion and belonging are fundamental to our culture and values. We are 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 you need a reasonable accommodation for any part of the application process due to a medical condition or disability, please let us know or submit a request via our careers site.
Work location
Work model: On-site
Planifyr
Key Responsibilities
- check_circleServe as primary point of contact between investigational sites and the sponsor
- check_circleConduct site selection, initiation, routine monitoring, and close-out visits
- check_circleEnsure site compliance with ICH-GCP, SOPs, and regulatory requirements
- check_circleMaintain up-to-date documentation in CTMS and eTMF systems
- check_circleMonitor patient safety and ensure timely AE/SAE/PQC reporting
- check_circleResolve data queries and drive timely, high-quality data entry
- check_circleOversee drug accountability and ensure proper storage, return, or destruction
- check_circleSupport subject recruitment and retention efforts at the site level
- check_circleTrack site budgets and ensure timely site payments
- check_circleCollaborate with cross-functional partners including CTAs, LTMs, and CTMs
Requirements
- verifiedBachelor's degree in Life Sciences or equivalent
- verifiedQualified RN
- verifiedEligible to work in United States without visa sponsorship
- verified2+ years of on-site monitoring experience in pharmaceutical or CRO industry
- verifiedProficient in ICH-GCP and local regulatory requirements
- verifiedProficient in CTMS and eTMF systems
Nice to Have
Preference given to candidates residing in Utah near major HUB airports to support efficient regional travel.
Benefits & Perks
check_circleVarious annual leave entitlementscheck_circleA range of health insurance offerings to suit you and your family's needscheck_circleCompetitive retirement planning offerings to maximize savingscheck_circleGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals
Similar Job Opportunities
Skills, education and keywords
Skills: Ich-GCP, CTMS, Etmf, Ae/sae/pqc Reporting, Drug Accountability, Site Monitoring, Data Entry, Site Recruitment, Site Retention, Site Budget Tracking.
Education: Bachelor's degree in Life Sciences or equivalent, or qualified RN.
Frequently asked questions about Cra II at Investigative Reporters and Editors
What does a Cra II at Investigative Reporters and Editors do?expand_more
Day-to-day, the Cra II at Investigative Reporters and Editors will serve as primary point of contact between investigational sites and the sponsor; conduct site selection, initiation, routine monitoring, and close-out visits; ensure site compliance with ich-gcp, sops, and regulatory requirements; and maintain up-to-date documentation in ctms and etmf systems.
What are the requirements for this Cra II role?expand_more
Investigative Reporters and Editors is looking for candidates who meet the following requirements: Bachelor's degree in Life Sciences or equivalent; Qualified RN; Eligible to work in United States without visa sponsorship; 2+ years of on-site monitoring experience in pharmaceutical or CRO industry; Proficient in ICH-GCP and local regulatory requirements; and Proficient in CTMS and eTMF systems.
Where is the Cra II role at Investigative Reporters and Editors located?expand_more
Cra II at Investigative Reporters and Editors is based in Planifyr. This is a on-site role.
Is this Cra II job remote, hybrid, or on-site?expand_more
Investigative Reporters and Editors has listed this Cra II role as on-site.
How much experience is required for this Cra II role?expand_more
Cra II at Investigative Reporters and Editors typically requires 2+ years of relevant experience at the mid level level.
What skills do you need for the Cra II role at Investigative Reporters and Editors?expand_more
Key skills for Cra II at Investigative Reporters and Editors include Ich-GCP; CTMS; Etmf; Ae/sae/pqc Reporting; Drug Accountability; Site Monitoring; Data Entry; and Site Recruitment.
What education is required for Cra II at Investigative Reporters and Editors?expand_more
Educational requirements for this role: Bachelor's degree in Life Sciences or equivalent, or qualified RN.
What category does the Cra II role belong to?expand_more
Cra II at Investigative Reporters and Editors is part of the healthcare & nursing job category on Recrutus.