"Clinical Trials Coordinator"

The Clinical Trials Coordinator (entry level) is a 100% FTE position within the Department of Medicine and Division of Rheumatology. This position will be part of the CORE-CT team that conducts industry-sponsored clinical trials and focused on autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, myositis, scleroderma, and other related autoimmune inflammatory diseases at the University of Colorado Anschutz Medical Campus. This position will play an important role in the ongoing development of this growing program.

This position will be responsible for the overall organization and implementation of assigned study protocols/clinical trials, including study-start-up, subject recruitment, screening, consenting, and coordination of study procedures and data collection. This position will also be responsible for managing the regulatory activities of the protocols, including submission and maintenance of documents for IRB, and other regulatory agencies as specified by the protocol and reporting requirements.

• Research coordinator for industry sponsored clinical trials in rheumatologic or other related rheumatologic inflammatory diseases.
• Ensures compliance with Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP), Institutional Review Boards (IRB), Health Insurance Portability and Accountability Act (HIPAA), University of Colorado Hospital (UCH), University of Colorado Denver (UCD) and other pertinent regulatory agencies.
• Performs subject recruitment, screening, consenting, coordination of clinical visits/protocol procedures and data collection and data entry and query resolution.
• Collaborates with investigators, clinical staff, and research staff to ensure study procedures are performed per protocol.
• Conducts medical record review, subject study visits and provides protocol specific subject education.
• Performs phlebotomy and pharmacokinetic sampling and collects basic clinical measurements, including vital signs.