Open Rank Clinical Trial Coordinator (Entry – Senior) – Cardiology

University of Colorado

20d•Hybrid

About The Position

We are seeking a Clinical Trial Coordinator in the areas of interventional cardiology and imaging research, electrophysiology, and heart failure. This position will support multiple Industry Supported Clinical Trials, Federally Funded Clinical Trials, and Investigator-Initiated Clinical Trials. This position focuses primarily on the responsibility of data collection, interpretation and documentation of clinical research data, and meeting with research patients for study-related purposes. The amount of time spent on required tasks may shift depending on the needs of the department.

Requirements

Bachelor’s degree in biology, molecular biology, chemistry, genetics, or related 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.
One (1) year clinical research or related experience (Intermediate Level)
Two (2) years clinical research or related experience (Senior Level)
Applicants must meet minimum qualifications at the time of hire.
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.
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Nice To Haves

Bachelor’s degree in science or health related field.
Three (3) years of clinical research or related experience.
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Epic, Oncore, and Redcap training.
Experience with COMIRB, WIRB, or other IRB.
Prior industry clinical trial, EDC, and CTMS experience.

Responsibilities

Coordinate and support day-to-day clinical trial operations partnering with Principal Investigators and research leadership to ensure studies are conducted efficiently and according to protocol.
Screen, recruit, consent, and educate research participants including reviewing medical records, determining eligibility, conducting study visits, and maintaining accurate screening and enrollment documentation.
Ensure accurate and timely data collection and documentation including abstraction of source data, completion of Case Report Forms (CRFs), and entry into clinical trial databases and the electronic medical record (EPIC).
Maintain compliance with regulatory and institutional requirements including FDA regulations, IRB policies, study protocols, and departmental standard operating procedures.
Manage study logistics and coordination such as scheduling participant visits, coordinating clinical and ancillary services (e.g., labs, imaging, pharmacy), and ensuring study supplies and equipment are available and functional.
Support monitoring visits, audits, and regulatory submissions including preparation for sponsor monitor visits, responding to data queries, and assisting with IRB continuing reviews and study documentation.
Contribute to team success and continuous improvement including training and mentoring junior staff, serving as a primary coordinator on assigned studies, and assisting with process development, study start-up, and close-out activities as appropriate to level.