Clinical Trial Coordinator (Entry – Intermediate Level)

at  University of Colorado

JOB SUMMARY:

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.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or health related field.
• Two (2) 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.

QUALIFICATIONS

Application Materials Required: Cover Letter, Resume/CV, List of References
Job Category: Research Services
Primary Location: Hybrid
Department: U0001 - Anschutz Med Campus or Denver - 20169 - SOM-MED-Cardiology
Schedule: Full-time
Posting Date: Oct 30, 2024
Unposting Date: Ongoing
Posting Contact Name: Ashleigh Downs
Posting Contact Email: ashleigh.downs@cuanschutz.edu
Position Number: 0080813

• Assist with and oversee the day-to-day operations of clinical trials and studies and assists the PI and Divisional Clinical Trials Manager.
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required.
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures, and other regulatory guidelines.
• Adhere to research regulatory standards.
• Collect, code, and analyze data obtained from research in an accurate and timely manner.
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.