CRA 2, IQVIA Biotech
$87,200–$145,300 year
On-siteColumbus, Ohio, United States
Job Summary
Conduct site visits for selection, initiation, monitoring, and close-out in alignment with GCP, ICH guidelines, and study protocols. Collaborate with site staff to implement recruitment strategies, deliver protocol training, and assess adherence to ensure data integrity. Monitor study progress by tracking regulatory submissions, enrollment, CRF completion, and query resolution while maintaining TMF and ISF documentation. Document visit outcomes and follow-up actions through detailed reports. Support cross-functional teams on site-level recruitment planning, financial management, and invoice collection. Requires at least one year of on-site monitoring experience in CAR-T or Cell & Gene Therapy.
Required Qualifications
- Bachelor's degree in life sciences or health-related field (or equivalent experience)
- At least 1 year of on-site monitoring experience
- Strong understanding of GCP, ICH guidelines, and regulatory requirements
- Ability to travel as required by the project
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