Open Rank Clinical Research Coordinator (Entry - Senior)

University of Colorado; United States; On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical plan options

Dental plan options

Retirement 401(a) plan

Paid time off

Job summary

University of Colorado is seeking a Clinical Research Coordinator to coordinate and support clinical studies within the Infectious Diseases Clinical Trials Unit (IDCTU) at the Anschutz Medical Campus. The role involves managing day-to-day trial activities, recruitment, consent, and data management, working with a multidisciplinary team on regulatory compliance.

The position emphasizes collaboration with investigators, sponsors, and monitors, ensuring records are complete and compliant while

Qualifications

• Bachelor's degree required; advanced degree may substitute for experience.
• 1 year clinical research experience for Entry/Intermediate level; 2 years for Senior level.
• Eligible to work in the United States without sponsorship.
• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Experience with study documentation and data management.

Responsibilities

• Coordinate day-to-day operations of clinical research studies per protocols and regulations.
• Serve as primary coordinator for assigned trials from recruitment to enrollment and follow-up.
• Coordinate recruitment and study visits, including informed consent and required procedures.
• Maintain accurate, complete study documentation and regulatory records.
• Manage study data, CRFs, data queries, and resolve data discrepancies.
• Collaborate with investigators, sponsors, monitors, and clinical/research teams to meet timelines.
• Support with study start-up/close-out and training of junior staff.

Skills

Communication skills

GCP knowledge

Regulatory knowledge

Bilingual English/Spanish

Education

Bachelor's degree in science or health related field

Bachelor's degree in any field

Tools

EMR/EHR systems

Electronic Data Capture (EDC)

Job description

Job Summary

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.

Key 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.

Work Location

Onsite - this role is expected to work onsite and is in Aurora, Colorado.

Why Join Us

The Division of Infectious Diseases is dedicated to improving health through outstanding patient care, innovative research, and transformative education. We provide expert, compassionate, and collaborative infectious disease care, advance the field through scientific discovery, promote best practices in antimicrobial stewardship and infection prevention, and train the next generation of clinicians and physician-scientists.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage .

Qualifications

Minimum Qualifications

• 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.
• Substitution: 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.

Preferred Qualifications

• 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.

Conditions of Employment

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.

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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.