Job Overview:
The Clinical Research Associate 2 (CRA 2) is responsible for monitoring and managing clinical trial sites to ensure adherence to study protocols regulatory requirements and guidelines. The CRA plays a key role in site management subject recruitment and data quality while maintaining clear communication with study teams and stakeholders.
Responsibilities:
- Conduct site monitoring visits including selection initiation monitoring and close-out visits in compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt drive and track subject recruitment plans in alignment with project needs to enhance predictability.
- Administer protocol and study-related training to assigned sites; establish regular communication to manage project expectations and address issues.
- Evaluate the quality and integrity of site practices to ensure proper conduct of the study protocol and adherence to regulations; escalate quality issues when necessary.
- Track and manage the progress of assigned studies including regulatory submissions recruitment and enrollment CRF completion and resolution of data queries; may support start-up phases as required.
- Verify that site documents including the Investigator's Site File (ISF) are maintained in compliance with GCP/ICH and local regulatory requirements; ensure availability for filing in the Trial Master File (TMF).
- Create and maintain documentation regarding site management monitoring findings and action plans including visit reports and follow-up letters.
- Collaborate and liaise with study team members for project execution support.
- Support development of project-specific subject recruitment plans for individual sites if applicable.
- May handle site financial management including retrieval of invoices as per local requirements.
Qualifications:
- Bachelor's Degree Degree in scientific discipline or healthcare preferred.
- 2 years of experience in clinical research and monitoring
- Advanced English (Des)
- In-depth understanding of clinical trial processes GCP and ICH guidelines.
- Strong analytical organizational and communication skills.
- Ability to manage multiple sites and effectively interact with research teams and stakeholders.
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.