IQVIA
Senior CRA 1 - Sponsor Dedicated
Gauteng based
Job Overview
As a Sponsor-Dedicated Senior Clinical Research Associate I (Sr CRA I), you will be responsible for monitoring and managing clinical trial sites for a dedicated sponsor, ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), applicable regulations, and sponsor expectations. This role offers the opportunity to work closely with a single sponsor, building strong partnerships and contributing to the successful delivery of clinical research programs.
Key Responsibilities
Conduct site selection, initiation, routine monitoring, and close-out visits.
Build strong relationships with study sites and support subject recruitment and enrollment activities.
Deliver study-related training and provide ongoing site support throughout the trial lifecycle.
Ensure protocol compliance, data quality, and adherence to regulatory requirements, escalating issues as needed.
Track study progress, including regulatory submissions, recruitment, data collection, and query resolution.
Maintain essential study documentation and ensure site files meet GCP and regulatory standards.
Prepare monitoring reports, follow-up communications, and other required study documentation.
Collaborate with cross-functional study teams to support successful project delivery.
Support study start-up, recruitment planning, and site financial activities, where applicable.
Qualifications
Bachelor’s degree in Life Sciences, Healthcare, or related field preferred; equivalent combination of education and experience will be considered.
Minimum 2 years of independent on-site clinical monitoring experience.
Strong knowledge of GCP, ICH guidelines, and clinical research regulations.
Ability to assess and manage site performance, quality, and compliance.
Proficiency with Microsoft Office applications and clinical trial systems.
Excellent communication, organizational, problem-solving, and stakeholder management skills.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
Frequent travel required based on study and business needs.
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. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.