Clinical Research Project Coordinator

Job Summary:

This position will participate as a member of the Cancer Center's Oncology Clinical Research Support Team (OCRST) in the development and implementation of Investigator Initiated research trials. This position will participate in writing and review of Investigator Initiated Trial (IIT) protocols, develop study tools such as PI oversight plan, registration forms, and other instructional tools that are needed to support the implementation and ongoing maintenance of IITs. This position works closely with clinical research teams to operationalize IITs but is not responsible for patient recruitment to clinical research projects. Performs tasks related to multicenter trial coordination including site feasibility evaluations, hosting teleconferences, and performing registration/randomization activities.

Key Responsibilities:

Level I Duties (Intermediate)

• Assists Cancer Center Principal Investigators (PIs) in the development of local Investigator Initiated protocols by providing clinical and operational expertise as well as review for consistency of events.

• Responsible for assisting PIs in the development of the protocol and subsequent amendments for Investigator Initiated Trials to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies and guidelines for investigator initiated and multi-center trials.

• Works closely with the clinical research managers and staff in the areas where the trials will take place to ensure study as written is feasible for the disease site team; maintains processes that allow smooth transition of study to disease team once open. Perform initial submission of IITs to Protocol Review and Monitoring System (PRMS) and Human Subjects Research (HSR) Portal.

• Serves as primary contact for trials assigned and as such will be responsible for developing a communication plan as well as trial study tools and other instructional tools for the clinic teams.

• Performs administrative and oversight tasks for all participating institutions which may include registration and randomization activities, coordinating regular teleconferences with all participating institutions, compiling data for reporting to DSMC or other regulatory or oversight entity.

• Communicates with Finance Professional and Contracts Associate to ensure budget and contract progress in line with other study activation activities; escalate as necessary to PI and/or IIT Program Director.

• Works with PI and Data Specialist on development of electronic case report forms for trials utilizing OnCore, REDCap or Advarra databases.

• Assists PIs and study Biostatisticians with dose escalation and interim safety analyses.

• Delegates and oversees tasks related to Investigator Initiated Trials Program as appropriate to Program support staff or Data Specialist.

• Participates in activities related to development of best practices as related to conduct of IITs and multi-center trials.

• Facilitate site evaluation and feasibility assessments for multi-center Investigator Initiated Trials.

Level II Duties (Senior)

• Adheres to and conducts all duties related to the Project Coordinator Level I.

• Independently manages and provides support for more complex Investigator Initiated Trials (i.e. multi-site and Phase I trials) with a commitment to providing a high level of customer service.

• Recommends and drafts enhancements to SOP's, guidance documents or other tools/templates pertinent to project coordination activities.

• Assists Clinical Research Project Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking.

• Participates in activities related to training of clinical trial team staff on topics identified during communications, monitor visits and audits.

• Participates in onboarding and training activities for new members of the Project Coordinator team; serves as back up coverage during team absences.

• Follow up and track all operational activities related to the above to ensure activities and deliverables are being executed according to agreed upon timelines.

Level III Duties (Principal Professional)

• Adheres to and conducts all duties related to the Project Coordinator Level I and II.

• Acts as mentor to and participates in planning for and onboarding activities for new members of the Project Coordinator team; serves as back up coverage during team absences.

• Prepare meeting presentations and/or deliver trainings during meetings.

• Independently drafts proposals for enhancements to SOP's, guidance documents or other tools/templates pertinent to project coordination activities.

• Takes on special projects for team development (i.e. meeting with collaborators to refine/expand processes, development of new workflows, etc.).

• Assists Clinical Research Project Manager in defining areas for improvement around protocol development, data analysis, etc.

• Delegate and oversee tasks assigned to Data Specialist on projects in which acting as the primary project coordinator

• Acts as work lead in the collection and management of protocol data to inform process evaluations, team workload and performance metrics; may involve developing and implementing new processes and reports to improve effectiveness and efficiency of data collection and process evaluation.

• Manage more complex protocols in which new processes may need to be defined and act as subject matter expert to train other project coordinators on these processes to be instituted on subsequent trials.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Why Join Us:

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

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: 10/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.

To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness

Qualifications:

Minimum Qualifications:

Project Coordinator Level I (Intermediate)

• BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

• Substitution: A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

• One (1) year of professional clinical research experience.

Project Coordinator Level II (Senior)

• BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

• Substitution: A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

• Two (2) years of professional clinical research experience.

Project Coordinator III (Principal Professional)

• BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

• Substitution: A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

• Three (3) years of clinical research experience including at least two years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.

• ACRP, SOCRA or RAC certification is required.

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

Project Coordinator I

• Three or more years of research experience in an academic setting

• One year experience with investigator initiated multi-center studies

• Experience operationalizing clinical research studies

• Prior oncology experience

Project Coordinator II

• Three (3) years of professional clinical research experience including at least two years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.

• Understanding of medical terminology and technical writing experience

• Oncology research experience

• Experience working with investigator-initiated research

• Experience working in an academic setting

• Thorough knowledge of ICH/FDA guidelines

• Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year

Project Coordinator III

• Four (4) years of clinical research experience including at least three years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.

• Understanding of medical terminology and technical writing experience

• Previous mentoring experience

• Oncology research experience

• Experience working with investigator-initiated research

• Experience working in an academic setting

• Thorough knowledge of ICH/FDA guidelines

Knowledge, Skills and Abilities:

• Ability to problem solve and multi-task.

• Excellent computer skills. Proficient in Windows, MS Word, Excel.

• Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.

• Possesses an understanding of the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.

• Knowledge of basic human anatomy, physiology, medical terminology.

• Ability to communicate effectively and with a high level of professionalism across various stakeholders.

• Proficient in writing or creating documentation such as SOPs, guidance documents or other similar documents

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 (only use if a cover letter is necessary)

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: Ashley Visser, ashley.visser@cuanschutz.edu.

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by January 22, 2026. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as

• Level I (Intermediate): $52,721

• Level II (Senior): $56,995

• Level III (Principal): $65,545

The above salary range (or hiring range) represents the University's 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: http://www.cu.edu/node/153125

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we 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 hr.adacoordinator@cuanschutz.edu.

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 other vaccine 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, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.