DSMC Auditor (Open Rank)

Job Summary:

This full-time position will assist with the implementation and coordination of the auditing program as outlined by the CU Cancer Centers NCI-approved Institutional Data Safety Monitoring Plan to assure the highest quality safest and most precisely performed clinical cancer research.

Key Responsibilities:

Examples of Work Performed by the Clinical Research Auditor (all levels):

Ensures clinical trials at both internal and external sites subject to CU Cancer Center oversight are conducted recorded and reported in accordance with the protocol Standard Operating Procedures (SOPs) Good Clinical Practices (GCP) & Code of Federal Regulations.

Assures adherence to all research standards set forth by the International Council on Harmonization (ICH) Good Clinical Practices (GCP) Food and Drug Administration (FDA) the Office for Human Research Protections (OHRP) University of Colorado Hospital University of Colorado Denver (UCD) National Cancer Institute (NCI) and other pertinent regulatory agencies and adheres to institution SOPs.

Audits National Clinical Trial Network (NCTN) Investigator-Initiated (IITs) and Industry sponsored clinical trial protocols.

Applies knowledge of protocol design to assess the conduct of the protocol and evaluate trials for any protocol deviations and escalate unacceptable findings.

In collaboration with the DSMC Manager participates in the creation research and conduct of process and quality improvement projects.

Examples of Work Performed by Level II (Senior Professional)

Provides audit shadowing for new auditors reviews and helps develop DSMC and CU Cancer Center level SOPs Guidance Documents and Work Instructions.

Provides feedback and examples to foster collaboration with the Oncology Clinical Research Support Team (OCRST) Monitoring Manager to ensure consistent communication and facilitate escalation between the monitoring and auditing teams.

Acts as a resource for Investigators and their teams including answering questions advising on corrective/preventative action root cause analysis clarifying requirements resolving problems etc.

Examples of Work Performed by Level III (Principal Professional)

• Acts as the subject matter expert for clinical trials under the purview of the DSMC.
• Assists the DSM Manager in training new auditors.

Assists the DSMC Chair and the DSM Manager on strategic research objectives and evaluation benchmarks

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 states 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 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: 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: Qualifications:

Auditor Level I (Intermediate Professional):

Bachelors degree in nursing biology chemistry public health public administration social/behavioral sciences business or a related field from an accredited institution.

One year of clinical research experience.

Auditor Level II (Sr. Professional):

Bachelors degree in nursing biology chemistry public health public administration social/behavioral sciences business or a related field from an accredited institution.

One year of clinical research experience.

One year of experience auditing or monitoring clinical trials.

Auditor Level III (Principal Professional):

Bachelors degree in nursing biology chemistry public health public administration social/behavioral sciences business or a related field from an accredited institution.

One year of clinical research experience.

At least two (2) years of experience auditing or monitoring clinical trials.

Substitution for all levels: A combination of education and experience in a related medical profession (such as medical assistant RN RRT etc.) may be substituted for the bachelors degree on a year-for-year basis but cannot substitute for the required clinical research experience or the auditing experience.

Conditions of Employment:

Must possess a current and valid drivers license and/or reliable transportation for in-person audits.

Be willing to travel for out-of-state audits (very rare).

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

• At least two years of clinical research experience
• Oncology clinical research experience
• Clinical research regulatory experience
• Prior experience auditing clinical research at an Academic Medical Center
• Knowledge of NCI Toxicity and Tumor Evaluation Criteria
• Experience working on CAR T or other immunotherapy/adoptive cell therapy trials
• Experience developing Guidance Documents and SOPs
• Clinical Research Certification (i.e. Certified Research Coordinator (CRC) Certified Clinical Research Professional (CCRP or ACRP CP) or Certified Clinical Research Associate (CCRA))

Knowledge Skills and Abilities:

Knowledge of basic human anatomy physiology and medical terminology.

Working knowledge of Good Clinical Practice (GCP) FDA Rules and Regulations for clinical trials NIH guidelines ICH guidelines clinical trial HIPAA regulations and NCI common toxicity definitions.

Analytical Skills - Ability to interpret and master complex research protocol information.

Attention to Detail Work is accurate and details are not overlooked.

Communication Skills - Good command of the English language and ability to communicate effectively both written and verbal.

• Interpersonal Skills Ability to establish and maintain effective working relationships with employees at all levels; interacts with people in a friendly open honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains a high level of confidentiality.
• Customer Service Demonstrates a commitment to excellent customer service providing internal and external customers with information or assistance in resolving problems.
• Complex Problem Solving Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Adaptability Adapts quickly to change and can manage multiple priorities and deadlines in a calm organized manner; is open to new ideas and methods; can work independently and as part of a team.
• Planning and Organizing Sets priorities anticipates obstacles when planning manages time effectively to accomplish tasks.
• Technical Skills Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook MS Word MS Excel); ability to learn new technology.
  
  

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: Jessica Dry

Screening of Applications Begins:

Applications will be accepted until finalists are identified but preference will be given to complete applications received by March 6 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 HIRING RANGE (minimum 40^th posting max).

Level I (Intermediate) - $55495 - $70590

Level II (Senior) $59995 - $76314

Level III (Principal) - $68994 - $87761

If you have prior state-classified service in the same class series as this position your pay may be set at a higher amount per the state Step Pay Program implemented on July 1 2024. For more information about the Step Pay Program please visit the 2024 Step Pay Program for State of Colorado Employees DHR.

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: 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 .

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.