Open Rank Clinical Research Coordinator (Entry – Senior)

University of Colorado•Aurora, CO

3d•Onsite

About The Position

The Clinical Research Coordinator will be responsible for coordinating and supporting the conduct of clinical research studies within the Infectious Diseases Clinical Trials Unit (IDCTU) that is led by Dr. Thomas Campbell and Dr. Kristine Erlandson at the University of Colorado Anschutz Medical Campus.

Requirements

Entry Level: Bachelor’s degree in any field.
Intermediate Level: Bachelor’s degree in any field. One (1) year clinical research or related experience.
Senior Level: Bachelor’s degree in any field. Two (2) years of clinical research or related experience.
An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Applicants must meet minimum qualifications at the time of hire.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
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.

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).
Phlebotomy experience.
Bilingual proficiency in English and Spanish.

Responsibilities

Coordinate day-to-day operations of clinical research studies, independently managing study activities in accordance with study protocols, institutional requirements, FDA regulations, and ICH/GCP guidelines.
Serve as a primary coordinator for assigned clinical trials and research studies, managing study activities from recruitment through active enrollment and follow-up.
Coordinate participant recruitment and study visits, including pre-screening and screening, eligibility review, informed consent, participant education, scheduling, and protocol-required procedures and assessments.
Maintain study documentation to ensure research activities and records are accurate, complete, timely, and compliant with applicable regulatory, institutional, protocol, and sponsor requirements.
Manage clinical research data and study quality, including source documentation, data collection and entry, case report forms, data queries, monitoring activities, and resolution of data discrepancies.
Collaborate with investigators, sponsors, monitors, research participants, and multidisciplinary clinical and research teams to facilitate study activities, address operational issues, and meet study goals and timelines.
Support research operations and continuous improvement by developing study-specific workflows and tools, assisting with study start-up and close-out, identifying opportunities to improve processes, and providing guidance or training to junior research staff.