Clinical Research Associate

Job Summary
We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.

Responsibilities

• Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards.
• Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy.
• Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy.
• Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements.
• Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required.
• Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files.
• Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution.
• Ensure compliance with HIPAA regulations concerning patient confidentiality and data security.
• Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments.
• Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis.
• Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.

Experience

• Proven supervising experience in managing clinical trials or overseeing clinical research teams.
• Extensive knowledge of clinical trials management processes from initiation through close-out phases.
• Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange.
• Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management.
• Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable.
• Familiarity with statistical software used in clinical research for data analysis purposes.
• Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus.
• Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.

Pay: $51,498.23 - $62,019.38 per year

Work Location: In person