ORIEN Data Specialist (Level I, II, or III)

Job Summary:

The Oncology Clinical Research Support Team (OCRST) serves as a central resource and umbrella department for all CU Cancer Center members at all CU Cancer Center clinical partner sites including University of Colorado Hospital, Children’s Hospital, and the​ Rocky Mountain Regional Veterans' Affairs Medical Center. The resources and services provided are aimed at supporting clinical research across the CU Cancer Center research enterprise and fostering collaboration as well as standard and efficient practices in the conduct of varied clinical research projects. The purpose of the ORIEN Total Cancer Care (TCC) study is to create a nationwide database for cancer research. ORIEN aims to accelerate the progression of cancer research by collecting biological samples and data which is used by physicians to develop the most effective means to treat and diagnosis cancer.

Examples of Duties Performed

Entry Level:

• Assist with and oversee the day-to-day data collection and reporting activities of the Total Cancer Care Protocol (TCCP) and other studies as assigned
• Abstract study subject’s medical history and cancer treatment information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject’s case for inclusion in the TCCP
• Ensures accurate and timely data entry of patient data and other data abstracted from clinical record into research database as assigned and updates patient research database records to ensure that they are accurate and complete
• Maintains 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
• Adheres to research regulatory standards
• Participates in quality assurance efforts as well as DSMC audits
• Abide by strict confidentiality regulations as defined by HIPAA and University policy and exercise integrity to protect patient confidentiality
• Seek guidance from senior staff and/or managers when data is missing and/or conflicts with other information
• Perform miscellaneous job-related duties as assigned

Intermediate Level, all the above and:

• Independently master study materials, including but not limited to protocols, data dictionaries, and all other essential study documents for TCCP and other studies as needed
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Assist and train junior team members
• Provides assistance with, extraction, transformation, analysis and reporting
• Completes all data input, error report analysis and correction, resolution of errors related to data entry, and assists with submission of data
• Participate in meetings as needed

Senior Level, all the above and:

• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), Guidance Document(s), work instructions, and Case Report Forms (CRFs)
• Assist with identifying issues related to operational efficiency, execute improvements, and share results with leadership
• Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention
• Synthesize and summarize data for stakeholders
• Utilize common data transformation platforms to develop data ETL skills under the supervision and mentorship of senior staff and/or managers

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Remote – this role is eligible to work remotely, but the employee must be in the United States.

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:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications

Entry Level 

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

Intermediate Level

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

• One (1) year clinical research experience in data management and/or abstraction

Senior Level 

• BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing, or other related discipline 
• Two (2) years’ clinical research experience in data management and/or abstraction

For all levels: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis

Preferred Qualifications

• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Advanced Excel skills including analytic functions (i.e., pivot tables, formulas, etc.)
• Experience working with SAS, R, SQL, or other data management platforms 
• Knowledge and understanding of cancer diagnosis and treatment standards
• Knowledge and understanding of ICD-O and histological coding
• Entry level proficiency and/or willingness to acquire data transformation skills using multiple programs (ie: Excel, SAS, relational databases, file transfer protocol (FTP) software)
• Experience analyzing data sets
• Utilize common data transformation platforms to develop ETL skills under the supervision and mentorship of senior staff and / or management
• Additional certification (one of the following):
  • CCDM - Certified Clinical Data Manager
  • CCRP – Certified Clinical Research Professional
  • CCRP – Certified Clinical Research Professional
  • CCRA – Certified Clinical Research Associate 

Competencies, Knowledge, Skills, and Abilities

• Knowledge and understanding of federal regulations, Good Clinical Data Management Practices (GCDMP) 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
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information
• Demonstrated analytical and researching ability
• Able to work under pressure and meet deadlines

Applicants must meet the minimum qualifications at time of application. 

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 (please be sure that all experience has month and year listed as well as year degree was earned)

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

Questions should be directed to: [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 14, 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

Entry: $47 084-59,891

Intermediate: $51 239-65,176

Senior = $55,393-70,460

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. Actual salary is dependent on relevant experience and education. This position is not eligible for overtime.

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:

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.

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 .