Senior Clinical Research Associate - Uganda job at IQVIA | Apply Now

Essential Functions

• Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, in line with the contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Collaborate with sites to adapt and track the subject recruitment plan to meet project needs and improve predictability.

• Provide training on the protocol and related study requirements to assigned sites, ensuring regular communication to manage project expectations and address any issues.

• Assess the quality and integrity of site practices to ensure compliance with protocol and regulatory standards, and escalate quality concerns when necessary.

• Oversee the progress of assigned studies, including tracking regulatory submissions, approvals, recruitment and enrollment, completion and submission of case report forms (CRFs), and resolving data queries. May also support the start-up phase.

• Ensure the proper documentation is available for the Trial Master File (TMF) and ensure the Investigator’s Site File (ISF) is maintained according to GCP/ICH and local regulatory standards.

• Document site management activities, monitoring visit findings, and action plans through visit reports, follow-up letters, and other required documentation.

• Mentor clinical staff by conducting co-monitoring and training visits.

• Collaborate with the study team to support project execution as needed.

• Manage site financials as per the clinical trial agreement and ensure the retrieval of invoices as required.

• If applicable, assist in developing and managing the project subject recruitment plan for each site.