Clinical Research Associate, Sponsor Dedicated, Oncology

IQVIA•Durham, NC

73d•$90,200 - $197,500

About The Position

As a Clinical Research Associate, you’ll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Requirements

BS Degree in a scientific discipline or healthcare preferred.
Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.
Effective time and financial management, and the ability to build strong working relationships.

Responsibilities

Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
Evaluate site practices for protocol adherence and escalate quality issues as needed.
Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.
Mentor clinical staff through co-monitoring and training visits.
Work closely with study team members to support project execution.
Manage site finances and retrieve invoices as per local requirements.