Clinical Research Associate (CRA)

About BrainChild Bio and Role Overview

BrainChild Bio, Inc. is seeking a detail-oriented and motivated Clinical Research Associate (CRA) to support and monitor clinical trials focused on CAR T cell therapies. This position will play a critical role in ensuring the quality, accuracy, and successful advancement of our autologous cell therapy clinical programs. The CRA will be part of the Clinical Operations team and will work collaboratively with internal Patient Operations staff, CRO partners, vendors, and clinical sites. The role offers an opportunity to impact an early-stage biotech by helping establish scalable clinical processes from inception.

Key Responsibilities

• Conduct both remote and on-site monitoring visits, including site qualification, initiation, routine monitoring, and close-out, following the monitoring plan.
• Perform thorough source data review and verification to guarantee data integrity and adherence to clinical protocols.
• Ensure timely entry of clinical data by sites in study systems, assist in data cleaning, handle query resolutions, conduct interim data evaluations, and support database lock preparations.
• Evaluate site compliance with GCP, protocols, institutional policies, and regulatory requirements.
• Identify and document deviations, safety events (AEs, SAEs, SUSARs), and data quality concerns; escalate issues when necessary.
• Assess site performance, enrollment progress, and readiness for key study milestones.
• Provide training to sites regarding protocol adherence, investigational product handling, and study procedures.
• Complete monitoring visit reports promptly, communicate follow-ups effectively, and ensure resolution of outstanding findings.
• Assist Clinical Operations in overseeing assigned clinical sites at a study level.
• Support coordination across functions such as inpatient/outpatient care, apheresis centers, cell processing labs, and radiology departments to ensure protocol compliance.
• Contribute to development and updates of study tools, training materials, and tracking documents as needed.
• Offer feedback to optimize monitoring processes, minimize redundancy, and enhance site operational efficiency.
• Collaborate with Clinical and Patient Operations teams to identify and resolve site performance, data integrity, and patient safety issues.
• Review essential documentation for completeness and assist in Trial Master File (TMF) quality and readiness for inspections.
• Participate in risk identification and mitigation activities related to site operations.
• Engage cross-functionally with teams such as Clinical Development, Safety, Data Management, and Quality to support trial execution.
• Maintain communication with external CRO partners, vendors, and site personnel to ensure smooth operation.
• Provide timely updates regarding site status, risks, and progress in resolving action items.

Required Qualifications

• Bachelor’s degree in a scientific or health-related discipline.
• At least 3 years of independent clinical trial monitoring experience within a CRO or sponsor setting, specifically involving Phase 2-3 clinical trials.
• Valid certification in Good Clinical Practice (GCP).
• Comprehensive knowledge of ICH E6 guidelines, FDA regulations, and clinical trial processes.
• Familiarity with clinical trial management tools, including Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and vendor portals.
• Strong communication, organizational, and time management capabilities.
• Willingness and ability to travel domestically up to 75% for on-site monitoring visits, including occasional short-notice trips.

Preferred Qualifications

• Experience monitoring oncology clinical trials, with a plus for pediatric or neuro-oncology exposure.
• Background in rare disease clinical studies or treating high acuity patient groups.
• Familiarity with cell therapy or gene therapy trials, particularly autologous therapies.
• Experience using risk-based monitoring and targeted source data verification methodologies.
• Knowledge of intricate studies involving central imaging, chain of custody protocols, or time-sensitive procedures.
• Track record of working effectively in dynamic, fast-paced environments.

Key Skills and Behaviors

• High attention to detail ensuring accurate data review and documentation.
• Ability to work independently, adaptable to evolving priorities and procedures.
• Proactive in identifying risks and resolving operational or site-specific challenges.
• Excellent interpersonal skills for building trust and effective communication with site teams and collaborators.
• Commitment to adhering strictly to GCP, protocols, internal policies, and regulatory standards.