Clinical Research Associate, Sponsor Dedicated

IQVIA•Durham, NC

6d•$64,000 - $189,000

About The Position

Perform monitoring and site management work to ensure that sites conduct studies and report study data in accordance with study protocols, applicable regulations and guidelines, and sponsor requirements. The role requires 65–70% nationwide travel and 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.

Requirements

At least 2.5 years of clinical research coordination experience at site level.
Nursing or university degree in one of the life sciences (US bachelor level or equivalent), or an equivalent combination of education, training, and experience.
Must reside in the same country where the job is located.
Position requires 65–70% nationwide travel.

Nice To Haves

Knowledge of electronic data capture.

Responsibilities

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