Clinical Research Associate, Sponsor Dedicated

IQVIA•Overland Park, KS

About The Position

Perform monitoring and site management work to ensure study sites conduct studies and report data in accordance with study protocols, applicable regulations and guidelines, and sponsor requirements. This position requires 65–70% nationwide travel. Candidates must reside in the same country where the job is located; experienced candidates near major hub airports in the Southeast, Northeast, Central, and West regions are sought. The role includes monitoring visits, site training and communication, oversight of site practices and study progress, and documentation of monitoring findings and action plans. The Clinical Research Associate collaborates with study team members and may support study start-up, subject recruitment planning, and site financial management. Minimum recruitment standards include 2.5 years of site-level clinical research coordination experience and a nursing or university degree in life sciences at the US bachelor level or equivalent. Equivalent combinations of education, training, and experience are considered. Knowledge of electronic data capture is preferred.

Requirements

At least 2.5 years of clinical research coordination experience at the site level.
Nursing or university degree in one of the life sciences at the US bachelor level or equivalent.
Equivalent combinations of education, training, and experience are considered.
Must reside in the same country where the job is located.

Nice To Haves

Knowledge of electronic data capture.
Experienced candidates near major hub airports in the Southeast, Northeast, Central, and West regions are sought.

Responsibilities

Perform site selection, initiation, monitoring, and close-out visits in accordance with the contracted scope of work and regulatory requirements, including GCP and ICH guidelines.
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
Administer protocol and related study training to assigned sites and establish regular communication to manage project expectations and issues.
Evaluate the quality and integrity of study site practices, including adherence to the protocol and applicable regulations, and escalate quality issues as appropriate.
Track regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution; may support the start-up phase.
Ensure required site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained according to GCP/ICH and local regulatory requirements.
Document site management and monitoring visit findings and action plans through visit reports, follow-up letters, and other required study documentation.
Collaborate and liaise with study team members to support project execution.
May support development of a project subject recruitment plan on a per-site basis.
May manage site finances according to the executed clinical trial agreement and retrieve invoices according to local requirements.