Clinical Research Associate (CRA)

BrainChild Bio, Inc. is seeking a motivated and detail driven Clinical Research Associate (CRA) to support the execution and monitoring of our CAR T clinical trials. This role will contribute directly to the quality, integrity, and success of our clinical programs as we advance our autologous cell therapy candidates. 

The CRA will be a member of the Clinical Operations team and collaborate closely with our internal Patient Operations team, Contract Research Organization (CRO) partners, vendors, and clinical trial sites to ensure study conduct is compliant with Good Clinical Practice (GCP), applicable regulations, and internal procedures. This is an exciting opportunity to join a growing early-stage biotech where you will have meaningful impact, broad exposure, and the ability to help build scalable clinical processes from the ground up. 

Key Responsibilities: 

Site Management and Monitoring 

• Conduct remote and on-site monitoring visits in accordance with the monitoring plan, including site qualification, site initiation, routine monitoring, and close out activities 

• Perform source data review (SDR) and verification (SDV) to ensure data accuracy, completeness, and alignment with our clinical trial protocols 

• Ensure sites enter clinical data into applicable study systems within required timelines and support ongoing data cleaning activities, including query resolution, interim data reviews, and database lock readiness. 

• Assess site compliance with GCP, protocol requirements, institutional policies, and regulatory expectations 

• Identify, document, and track protocol deviations, safety events/trends (AEs, SAEs, SUSARs, etc.), and data quality issues, escalating concerns as needed 

• Evaluate site performance, enrollment progress, and readiness for key study milestones 

• Support site training on protocol requirements, investigational product handling, and study procedures 

• Complete monitoring visit reports within required timelines, issue timely follow up correspondence to clinical sites, and ensure resolution of outstanding action items and findings 

Study Conduct Support 

• Assist Clinical Operations team with study level oversight of assigned sites 

• Support study conduct across multiple site functions, including inpatient/outpatient care teams, apheresis centers, cell processing laboratories, local laboratories, and radiology departments, to ensure coordinated execution of protocol requirements. 

• As needed, support development, revision, and execution of study tools, checklists, training materials, and tracking documents 

• Provide ongoing feedback on opportunities to streamline monitoring processes, reduce redundancy, and improve operational efficiency at the site level. 

• Collaborate with Clinical Operations and Patient Operations teams to resolve operational issues that impact site performance, data integrity, and patient safety 

• Review essential documents for completeness and assist with TMF quality and inspection readiness