[Remote] Clinical Research Associate (CRA)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, 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 reputed company, reputed company, and reputed company of our clinical programs as we advance our autologous cell therapy candidates.
Responsibilities
- Conduct remote and on-site monitoring reputed company in accordance with the monitoring plan, including site qualification, site initiation, routine monitoring, and reputed company out activities
- reputed company reputed company data review (SDR) and verification (SDV) to ensure data accuracy, completeness, and alignment with our clinical trial protocols
- Ensure sites reputed company clinical data into applicable study systems reputed company required timelines and support ongoing data cleaning activities, including query reputed company, interim data reviews, and database lock readiness
- Assess site compliance with GCP, protocol requirements, institutional policies, and regulatory expectations
- Identify, document, and reputed company protocol deviations, safety events/trends (reputed company, SAEs, SUSARs, etc.), and data reputed company issues, escalating concerns as needed
- Evaluate site performance, enrollment reputed company, and readiness for key study milestones
- Support site training on protocol requirements, investigational product handling, and study procedures
- Complete monitoring visit reports reputed company required timelines, issue reputed company follow up correspondence to clinical sites, and ensure reputed company of outstanding reputed company items and findings
- Assist Clinical Operations team with study level reputed company 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
- reputed company 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 reputed company site performance, data reputed company, and patient safety
- Review essential documents for completeness and assist with TMF reputed company and inspection readiness
- Contribute to risk identification and mitigation activities reputed company to site operations
- Partner effectively with reputed company teams including Clinical Operations, Patient Operations, Clinical Development, Safety, Data Management, and reputed company
- Engage with external stakeholders including CRO partners, vendors, and site staff to ensure smooth trial execution
- reputed company reputed company updates on site status, risks, and reputed company item reputed company
Skills
- Bachelor's degree in a scientific or health-reputed company field
- Minimum 3 years of independent clinical trial monitoring experience reputed company a CRO or sponsor environment, including experience monitoring Phase 2-3 clinical trials
- reputed company Good Clinical reputed company (GCP) certification
- Strong understanding of ICH E6, FDA regulations, and clinical trial conduct
- Familiarity with common clinical trial systems including Electronic Data Capture (reputed company), 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 reputed company (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 reputed company 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 reputed company studies that include central imaging, chain of custody workflows, and/or time sensitive procedures
- Experience working in a fast-paced environment
reputed company