Senior Clinical Research Associate, Sponsor Dedicated, Gauteng Based - Centurion at IQVIA

Job Overview

• The Senior Clinical Research Associate I (Sr CRA I) is responsible for monitoring and site management activities for asthma and respiratory clinical trials to ensure study conduct, subject safety, and data quality in compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, and sponsor requirements.

Key Responsibilities

• Perform on-site monitoring visits (site selection, initiation, routine monitoring, and close-out) for asthma studies in accordance with GCP and contracted scope of work.
• Support investigative sites in executing asthma-specific recruitment strategies, including identification of eligible subjects based on disease severity, lung function criteria, and exacerbation history.
• Deliver protocol, asthma disease, and study-specific training, including procedures related to spirometry, FeNO, ePRO/eDiary use, and inhaler technique assessments.
• Review and assess site compliance with protocol requirements, including eligibility criteria, rescue and maintenance medication use, exacerbation management, and safety reporting.
• Monitor data quality and integrity for asthma endpoints such as lung function assessments, symptom scores, diary compliance, and adverse event reporting; escalate quality issues as needed.
• Track study progress, including regulatory submissions, enrollment, CRF completion, and query resolution; may support study start-up activities.
• Ensure essential documents are complete and filed accurately in the Trial Master File (TMF) and Investigator Site File (ISF) in accordance with GCP and local regulatory requirements.
• Prepare and maintain monitoring documentation, including visit reports, follow-up letters, and action plans related to site performance.
• Collaborate closely with cross-functional study team members (e.g., Clinical Operations, Data Management, Medical) to support successful trial execution.
• May support site-level recruitment planning and site financial management, including invoice review, as applicable.

Qualifications and Skills

• Bachelor’s degree in a scientific or healthcare-related discipline.
• Minimum of 3 years of on-site clinical trial monitoring experience, preferably within respiratory or asthma studies.
• Strong working knowledge of GCP, ICH guidelines, and applicable clinical research regulatory requirements.
• Familiarity with asthma clinical trial procedures, endpoints, and safety considerations is preferred.
• Proficiency in Microsoft Office and clinical trial systems; comfortable using mobile technology.
• Strong written and verbal communication skills with a good command of English.
• Excellent organizational, problem-solving, and time management skills.
• Ability to build and maintain effective working relationships with sites, colleagues, managers, and clients.