Research Coordinator/ Medical Assistant

Job Overview
We are seeking a dynamic and detail-oriented Research Coordinator/Medical Assistant to join our clinical research team. This role is vital in coordinating and supporting clinical trials, ensuring compliance with regulatory standards, and providing exceptional patient care. The ideal candidate will possess a strong foundation in medical terminology, clinical procedures, and research protocols, with a passion for advancing medical knowledge through meticulous data collection and management. This paid position offers an exciting opportunity to contribute to groundbreaking research projects while developing your skills in clinical development and regulatory compliance.

Duties

• Assist in the planning, organization, and execution of clinical trials, ensuring adherence to study protocols and regulatory guidelines such as FDA regulations and ICH GCP standards
• Conduct patient monitoring by taking vital signs, performing blood sampling (phlebotomy), and documenting clinical observations accurately within electronic medical records (EMR) systems
• Review and verify study documentation for accuracy, completeness, and compliance with protocol requirements
• Manage data collection, entry, and management using statistical software and CDISC standards to ensure high-quality data integrity
• Support clinical laboratory procedures, including specimen handling and processing, while maintaining strict compliance with HIPAA privacy regulations
• Supervise or assist with research staff training on Good Clinical Practice (GCP) and study-specific procedures
• Monitor patient safety throughout the trial process, including adverse event reporting and compliance management
• Collaborate with investigators, sponsors, and regulatory bodies to ensure smooth trial operations and adherence to all applicable guidelines

Experience

• Proven supervising experience in a clinical or research setting, demonstrating leadership in managing teams or projects
• Hands-on experience managing clinical trials from initiation through closeout phases
• Strong knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques (phlebotomy)
• Familiarity with EMR systems, data management tools, statistical software, and CDISC standards for data collection and analysis
• Understanding of FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and clinical development processes
• Certification in Good Clinical Practice (GCP) from a recognized issuer such as the ICH GCP certificate or equivalent is required; valid certification for California (CA) preferred
• Experience working within clinical research environments involving blood sampling, vital signs assessment, and patient monitoring
• Ability to review complex documentation meticulously while maintaining high standards of compliance and accuracy

Join us in advancing innovative healthcare solutions! This role offers the chance to work at the forefront of clinical research while honing your skills in a collaborative environment dedicated to excellence. We value motivated professionals eager to make a difference through meticulous research practices combined with compassionate patient care.

Pay: $35,500.96 - $50,000.00 per year

Work Location: In person