Clinical Research Associate Sponsor Dedicated - IQVIA Kansas City
Overview
You will own site monitoring and management for sponsor-dedicated studies, ensuring protocol compliance and data integrity across 5PY and other trials. You will conduct selection, initiation, monitoring, and close-out visits while applying GCP and ICH guidelines. Working onsite in Kansas City, you will collaborate with cross-functional teams to drive recruitment and resolve site issues. This role stands out for its direct sponsor focus and the chance to impact study outcomes from start-up to close-out.
What You'll Do9
- 1Conduct selection, initiation, monitoring, and close-out visits per GCP and ICH guidelines while following the contracted scope of work.
- 2Drive subject recruitment plans with sites, adapting timelines to meet project enrollment targets within the first 90 days.
- 3Administer protocol training to site staff and maintain regular communication to manage study expectations and resolve issues.
- 4Evaluate site practices for protocol compliance and escalate quality issues to maintain data integrity.
- 5Track regulatory submissions, approvals, and enrollment metrics, ensuring timely CRF completion and query resolution.
- 6Verify site documents for the TMF and ensure the ISF aligns with GCP and local regulations.
- 7Submit visit reports and follow-up letters documenting findings and action plans for each site visit.
- 8Collaborate with study team members to support project execution and achieve study milestones.
- 9Manage site financial agreements and invoices per the clinical trial agreement when applicable.
Requirements8
- 1Bachelor's Degree in a scientific discipline or healthcare preferred, or equivalent combination of education and training.
- 2Completion of a CRA training program or prior monitoring experience required by some organizations.
- 3Knowledge of GCP and ICH guidelines for clinical trial conduct.
- 4Computer proficiency in Microsoft Word, Excel, and PowerPoint, plus laptop and mobile device usage.
- 5Written and verbal communication skills with command of the English language.
- 6Organizational and problem-solving skills to manage multiple site activities.
- 7Time and financial management skills to handle site budgets and timelines.
- 8Ability to build effective working relationships with coworkers, managers, and clients.
Salary Insight
$72 - $189k per year
Location
Required Skills
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