University of Colorado Anschutz Medical Campus

Department: Medicine – Division of Rheumatology

Job Title: Open Rank Clinical Trials Coordinator (Intermediate – Senior)

Position #: 00850321 – Requisition #: 40492

Job Summary:

The Clinical Trials Coordinator is a 100% FTE position within the Department of Medicine and Division of Rheumatology. This position will be part of a team that conducts industry-sponsored clinical trials focused on autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis 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.

The Clinical Trials Coordinator 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, hospitals, and sponsors, as specified by the protocol and reporting requirements. They will serve as the liaison between sponsors, investigators and study subjects.

Key Responsibilities:

• Research coordinator for industry sponsored clinical trials in rheumatologic or other related rheumatologic inflammatory disease.

• 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.

Work Location:

Onsite – this role is expected to work onsite and is located in Aurora, CO.

Why Join Us:

The Division of Rheumatology has a strong clinical research program that includes an expanding clinical trials program and highly impactful observational studies led by investigators who are leading experts in the field. Our clinical trials program is dedicated to bringing cutting-edge advances in treatments to our patients. Team members are part of a cohesive and collaborative team dedicated to having a positive impact on individuals suffering from the complications of autoimmune diseases.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including: