Senior Clinical Research Associate, Sponsor Dedicated, Gauteng based

Senior Clinical Research Associate I (Sr CRA I)

Sponsor Dedicated

Gauteng Based

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

• Bachelors 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.