Clinical Research Assistant

Overview

Join our dynamic team as a Clinical Research Assistant and be at the forefront of advancing healthcare through meticulous research and innovative clinical trials. This paid position offers an exciting opportunity to contribute to cutting-edge medical studies, ensuring compliance with regulatory standards while supporting the development of new therapies and treatments. You will play a vital role in coordinating research activities, managing data, and ensuring the integrity and quality of clinical investigations in a fast-paced research environment.

Responsibilities

• Assist in the planning, coordination, and execution of clinical trials in accordance with ICH GCP (International Conference on Harmonisation Good Clinical Practice) guidelines and FDA regulations.
• Review and maintain accurate documentation, including patient records, consent forms, and trial protocols, ensuring compliance with healthcare privacy laws such as HIPAA.
• Monitor patient progress throughout clinical studies, including administering blood sampling procedures and tracking adverse events.
• Support data collection, entry, and management using electronic medical record (EMR) systems and CDISC (Clinical Data Interchange Standards Consortium) standards for data standardization.
• Conduct site visits to ensure adherence to clinical quality assurance standards and regulatory requirements.
• Collaborate with project managers to oversee research project timelines, milestones, and deliverables.
• Assist in training staff on clinical research methods, ethical guidelines, and compliance management practices to uphold high standards of research integrity.

Experience

• Prior experience working within a clinical research setting or healthcare environment is highly preferred.
• Demonstrated supervising experience in managing research teams or study sites is advantageous.
• Strong knowledge of medical terminology, clinical laboratory procedures, and clinical development processes.
• Proficiency in statistical software tools used for data analysis within research projects.
• Familiarity with EMR systems, Microsoft Office Suite, and data management platforms aligned with clinical trials management.
• Certification in ICH GCP (from any recognized issuer) or equivalent certification such as an ICH Good Clinical Practice (GCP) certificate is required.
• Understanding of FDA regulations, HIPAA compliance standards, and healthcare ethical guidelines is essential.
• Project management experience in healthcare or research settings will support success in this role.
• Excellent analysis skills combined with attention to detail to ensure accuracy in data collection and documentation review.

This position offers an engaging environment where your expertise directly impacts the future of medicine while providing opportunities for professional growth within a collaborative team dedicated to excellence in clinical research.

Pay: $24.96 - $30.06 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible schedule
• Health insurance
• Life insurance
• Parental leave
• Professional development assistance
• Relocation assistance
• Vision insurance

Work Location: In person