Clinical Research Associate, IQVIA Biotech at IQVIA in Fort Worth, TX

Summary: IQVIA is a leading global provider of clinical research services, and they are seeking a dedicated Clinical Research Associate (CRA) to join their team. The CRA will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations, directly contributing to the integrity and quality of clinical research data. Responsibilities: - Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines - Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals - Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues - Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity - Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries - Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards - Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence - Work closely with cross-functional project teams to support study execution and ensure alignment with project goals - Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking Required Qualifications: - Bachelor's degree in life sciences or health-related field (or equivalent experience) - Requires 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 Required Skills: On-site clinical trial monitoring, Oncology solid tumor clinical research, Clinical Practice (GCP), ICH guidelines, Regulatory compliance, Clinical trial site management, Clinical trial documentation, Subject recruitment strategies Benefits: Incentive plans, Bonuses, Other forms of compensation, A range of health and welfare and/or other benefits