Senior Clinical Research Associate, Sponsor Dedicated

IQVIA•Overland Park, KS

About The Position

The Senior Clinical Research Associate performs monitoring and site management work to ensure study sites conduct studies and report study data in accordance with study protocols, applicable regulations and guidelines, and sponsor requirements. The role includes site monitoring and management throughout the study, supporting recruitment, training site personnel, evaluating site quality and compliance, tracking study progress, and maintaining required documentation. The position is sponsor-dedicated. Applicants must reside in the same country where the job is located.

Requirements

At least 3 years of on-site monitoring experience.
Good knowledge of and ability to apply applicable clinical research regulatory requirements, including GCP and ICH guidelines.
Good therapeutic and protocol knowledge, as provided in company training.
Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint, and use of a laptop computer, iPhone, and iPad where applicable.
Written and verbal communication skills, including good command of English.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Must reside in the same country where the job is located.

Nice To Haves

Bachelor's degree in a scientific discipline or healthcare field is preferred.

Responsibilities

Perform site selection, initiation, monitoring, and close-out visits in accordance with the contracted scope of work and Good Clinical Practice.
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
Provide protocol and related study training to assigned sites and maintain 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 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 and verify the Investigator's Site File is maintained according to GCP and local regulatory requirements.
Maintain site management and monitoring documentation, including visit reports, follow-up letters, findings, action plans, and other required study documentation.
Collaborate with and support study team members in project execution.
When applicable, support development of a project subject recruitment plan for each site.
When applicable, manage site finances according to the executed clinical trial agreement and retrieve invoices according to local requirements.