Clinical Research Auditor I, II, III (Open Rank)

Job Summary:

The Data and Safety Monitoring Committee (DSMC) at the University of Colorado Cancer Center is seeking to employ a full time Clinical Research Auditor. Depending on qualifications and department needs, appointments may be made from an Entry to Senior level Auditor.

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

Key Responsibilities:

• 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 (GCPs) & 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 conduct of protocol and evaluate trials for any protocol deviations and escalate unacceptable findings.
• Reviews and helps develop DSMC and CU Cancer Center level SOPs, Guidance Documents and Work Instructions.
• 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 and III

• Acts as the subject matter expert for clinical trials under the purview of the DSMC.
• Trains new auditors.
• Assists the DSMC Chair and Director on strategic research objectives and evaluation benchmarks.
• Liaisons with the Oncology Clinical Research Support Team Monitoring Manager to ensure consistent communication and facilitate escalation between monitoring and auditing team.
• Acts as a resource for investigators and their teams (this includes answering questions, advising on corrective/preventative action, root cause analysis, clarifying requirements, resolving problems, etc.).

Work Location:

Hybrid – this role is eligible for a hybrid schedule 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.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness .

Diversity and Equity:

DIVERSITY, EQUITY, INCULSION AND ACCESS

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center. 

If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at [email protected] to request an accommodation in accordance with the Americans with Disability Act.

Qualifications:

Minimum Qualifications:

Auditor Level I (Intermediate Professional):

• Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a related field from an accredited institution.
• Two years of clinical research experience. 

Auditor Level II (Sr. Professional):

• Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a related field from an accredited institution.  
• Three (3) years of clinical research experience. 
• One year of experience auditing or monitoring clinical trials. (This experience can be included in the Clinical Research experience above).

Auditor Level II (Sr. Professional):

• Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a related field from an accredited institution.  
• Three (3) years of clinical research experience. 
• One year of experience auditing or monitoring clinical trials. (This experience can be included in the Clinical Research experience above).

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

Conditions of Employment:

• Must possess a current and valid driver’s license and/or reliable transportation for in-person audits.
• Be willing to travel for out-of-state audits (very rare).

Conditions of Employment for Auditor Level I and Level II:

• Must possess OR obtain within 1 year of employment a current Clinical Research Certification (i.e., Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP-CP), or Certified Clinical Research Associate (CCRA)). CU Cancer Center will support employees in this endeavor.

Conditions of Employment for Auditor III:

• Must possess and maintain a valid Clinical Research Certification (i.e., Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP-CP), or Certified Clinical Research Associate (CCRA)).

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Oncology clinical research 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 SOPs

Knowledge, Skills and Abilities:

Knowledge of basic human anatomy, physiology medical terminology as well as 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.

• 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 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 is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
• Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, 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

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: Anna-Marie Locher, [email protected]

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by February 21, 2024. 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

Intermediate: $52,936-67,334

Senior: $57,228-72,794

Principal: $65,812-83,713

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

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 [email protected] ​.

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 .