Note: The job is a remote job and is open to candidates in USA. 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.
Responsibilities
- 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
- 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
- Contribute to risk identification and mitigation activities related to site operations
- Partner effectively with internal and external teams including Clinical Operations, Patient Operations, Clinical Development, Safety, Data Management, and Quality
- Engage with external stakeholders including CRO partners, vendors, and site staff to ensure smooth trial execution
- Provide timely updates on site status, risks, and action item resolution
Skills
- Bachelor's degree in a scientific or health-related field
- Minimum 3 years of independent clinical trial monitoring experience within a CRO or sponsor environment, including experience monitoring Phase 2-3 clinical trials
- Current Good Clinical Practice (GCP) certification
- Strong understanding of ICH E6, FDA regulations, and clinical trial conduct
- Familiarity with common clinical trial systems including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and vendor portals
- Excellent communication, organizational, and time management skills
- Willingness and ability to travel up to 75% for on-site monitoring visits (domestic travel; occasional short notice travel may be required)
- Prior oncology monitoring experience; pediatric or neuro-oncology exposure is a plus
- Experience in rare disease studies or high acuity patient populations
- Background in cell therapy or gene therapy trials, especially autologous programs
- Experience with risk-based monitoring (RBM) and targeted SDV models
- Familiarity with complex studies that include central imaging, chain of custody workflows, and/or time sensitive procedures
- Experience working in a fast-paced environment
Company Overview