Open Rank Clinical Trials Coordinator (Intermediate – Senior)

University of Colorado•Aurora, CO

8d•Onsite

About The Position

The Clinical Trials Coordinator is a full-time (1.0 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. This position will take a lead in clinical trials using chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases. 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.

Requirements

Bachelor’s degree in any field.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Two (2) year clinical research or related experience. (Intermediate Level)
Three (3) years clinical research or related experience. (Senior Level)
Applicants must meet minimum qualifications at the time of hire.
Applicants must be legally authorized to work in the United States without requiring sponsorship.

Nice To Haves

Bachelor’s degree in science or health related field.
Four (4) years of clinical research or related experience.
Experience with clinical trials in oncology, hematology or using CAR-T or cellular based therapy.
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Experience working in OnCore.
SOCRA or ACRP certification.
Phlebotomy experience.
Previous research experience in an academic or university-based environment.
MD, DO, or equivalent clinical medical degree.
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Ability to move projects forward and get various groups of people working together for shared outcomes.

Responsibilities

Research coordinator for industry sponsored clinical trials in rheumatologic or other related rheumatologic inflammatory disease, with a primary focus on CAR-T trials.
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.