Open Rank Clinical Research Coordinator (Intermediate – Senior)

Job Summary:

As an important member of the research team, the Clinical Research Services Professional works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills, a high standard of professionalism, and accepts responsibility in maintaining relationships that are equally respectful to all. This position is responsible for the implementation and coordination of clinical trials and investigator-initiated studies conducted by Dr. Sachin Wani and colleagues at the University of Colorado.

For this position specifically, we are seeking a member to join Dr. Wani and his research team at the University of Colorado Anschutz Medical Campus. The successful candidate will be a part of a team that includes supportive research personnel (regulatory, budget, coordinators) and medical personnel, all led by the principal investigator and the GI division research leadership. The candidate will participate in clinical research projects including studies examining esophageal diseases and therapeutic endoscopy. The position requires an ability to work independently but collaboratively, have attention to detail, and be able to maintain organized protocol documentation and data. Furthermore, the Clinical Science Professional will have the opportunity to manage and lead teams. The studies we conduct require in-person and telephone interactions with participants/patients/staff; thus, we are seeking a candidate who is a “people person” and can interact well with others.

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 initiation through active enrollment, follow-up, and study closeout.

• 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 regulatory and 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, CO.

Why Join Us:

The Division of Gastroenterology and Hepatology in the Department of Medicine

at the University of Colorado Anschutz Medical Campus is an internationally recognized program that provides comprehensive resources for the diagnosis and treatment of diseases of the digestive tract, pancreas, and liver. The Division has faculty and staff making significant contributions to clinical research, clinical trials, and nationally recognized patient care. With clinical practices throughout the state of Colorado and more than 80 researchers, physicians, and staff, the Division is rapidly expanding its research and clinical footprint. The Division’s vision is to prevent and treat digestive diseases while serving as a global model for patient care delivery, interdisciplinary research, and training.

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:

Intermediate Level:

• Bachelor’s degree in any field.

• One (1) year of clinical research or related experience.

  • Substitution: An advanced degree (Masters or PhD) 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.

Senior Level:

• Bachelor’s degree in any field.

• Two (2) years of clinical research or related experience.

  • Substitution: An advanced degree (Masters or PhD) 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 (All Levels):

• 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).

• Experience with project management, financial coordination, and regulatory oversight.

Conditions of Employment (All Levels):

• 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 (All Levels):

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).