Senior Research Project Coordinator

Job Summary:

As an important member of the research team the Clinical Research SURVENT Project Coordinator 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. The Project Coordinator communicates appropriately and effectively with study subjects investigators and other team members and has outstanding customer service skills 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.

Key Responsibilities:

• Assist with and oversee the day-to-day operations of clinical trials and studies.

• 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.

• Independently perform study related processes procedures and assessments as defined in study protocol and in compliance with regulating bodies.

• Assist with developing or develops protocol-specific systems and documents including process flows training manuals Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents equipment and/or supplies.

• Coordinate and track regulatory submissions and documentation including site regulatory packets amendments and required study updates.

• Assist with the preparation and execution of subcontracts and site agreements in collaboration with institutional administrative offices. Process and track site invoices and payments to ensure timely reimbursement to participating sites.

• Organize and coordinate a multi-site in-person investigator meeting including agenda development logistics and communication with participating investigators and stakeholders.

Work Location:

Onsite this role is expected to work onsite and is located 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 Divisions 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 haveAMAZINGbenefits and offerexceptional 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:

• Bachelors degree in any field.

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

  • 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:

• Bachelors 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.

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.

• Exceptional organizational skills.

• Demonstrated interpersonal skills.

• Ability to maintain professionalism and confidentiality in all interactions.

• Contribute to a collaborative research environment that promotes scientific excellence and respect for all individuals.

• Advanced proficiency with excel and other Microsoft Office programs.

How to Apply:

For full consideration please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.

2. Curriculum vitae / Resume

3. Three to five professional references including name address phone number (mobile number if appropriate) and email address.

Questions should be directed to:

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration apply by July 1^st 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $58705 $78665.

The above salary range (or hiring range) represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal state and local laws governing non-discrimination in employment. We are committed to creating a workplacewhere all individuals are treated with respect and dignity andwe encourage individuals from all backgrounds to apply including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act please contact the Human Resources ADA Coordinator at .

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty staff students and visitors. To assist in achieving that goal we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and othervaccine preventable diseases. If you work visit or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work visit or volunteer addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.