Impactful Clinical Trials Coordinator

OneOncology; Lone Tree (CO); On-site; USD 37,195,000 - 44,083,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Tuition reimbursement

Employee assistance program

Corporate discounts

Paid time off

Job summary

Colorado Urology is seeking a Research Coordinator to screen, enroll, and monitor subjects across Phase I–IV trials. You will work with the PI and staff to ensure protocol compliance and smooth site operations.

Responsibilities include coordinating recruitment, preparing study materials, maintaining regulatory documents, and ensuring HIPAA and FDA guidelines are followed. A high school diploma and clinical research experience are required.

Qualifications

• Minimum High School Diploma or GED required.
• Minimum of two (2) years of clinical research experience.
• Certification of accreditation (CCRC/IATA/CPR/NIH/CITI) required and will be verified prior to employment.

Responsibilities

• Screen, enroll, and follow study subjects for Phase I–IV trials.
• Review inclusion/exclusion criteria and protocol with PI/SI.
• Coordinate recruitment and communications with physicians and staff.
• Prepare study charts, source docs, and regulatory paperwork.
• Ensure FDA/ICH/GCP/HIPAA compliance and site SOP adherence.
• Document adverse events and maintain study drug dispensing logs.

Skills

Customer service

Attention to detail

Communication skills

Clinical assessment

Regulatory knowledge

GCP/ICH familiarity

HIPAA compliance

Multitasking

Education

High School Diploma or GED

2+ years clinical research experience

CCRC/IATA/CPR/NIH/CITI certifications

Tools

Computer software and databases

Job description

Colorado Urology is seeking a Research Coordinator to screen, enroll, and monitor subjects across Phase I–IV trials. You will work with the PI and staff to ensure protocol compliance and smooth site operations.

Responsibilities include coordinating recruitment, preparing study materials, maintaining regulatory documents, and ensuring HIPAA and FDA guidelines are followed. A high school diploma and clinical research experience are required.