Data Support Specialist (Intermediate)

Job Summary:

This position will participate as a member of the Cancer Center's Oncology Clinical Research Support Team (OCRST) and is responsible for providing data support for the Cancer Center Support Grant (CCSG) and other clinical research operations. This position is also responsible for registering and managing data within the Clinicialtrials.gov and Clinical Trial Reporting Program (CTRP) databases. This position will be required to collaborate across UCCC Clinical research teams, investigators and consortium member sites to fulfill reporting requirements and to support reporting for Cancer Center Support Grant (CCSG), the Lead Academic Participating Site (LAPS) U10, and the NCI Early Phase I and Phase II UM1 grants.

Key Responsibilities:

• Maintain existing clinical trials in CTRP and ClinicalTrials.gov including trial status updates, amendments, and ongoing IRB approvals per system requirements and institutional SOPs.40%
• Ensure timely submission of quarterly accruals into CTRP on all assigned applicable trials.10%
• Aggregate and review clinical data including research protocols, regulatory documents and other documents related to CTRP and ClinicalTrials.gov from a variety of sources ensuring accuracy, timeliness, confidentiality, and security of data. 10%
• Participate in tracking of registrations, updates and accruals to ensure compliance with regulatory requirements; identify and resolve problems that could interfere with meeting submission requirements. This also includes prompt recognition and appropriate referral of problems that require escalation. 10%
• Notify PI when study results are due in Clinicaltrials.gov and follow up to ensure this has been completed. 5%
• Monitor data to identify problems and /or inconsistencies in trials and patient enrollment data to those trials; recommend corrective action and escalate as appropriate. 25% inclusive of all remaining items
• Collaborate with clinical research team members across the UCCC to assure needed regulatory data and subject enrollment data is collected accurately and in a timely manner.
• Monitor notifications and reports from OnCore to track new trials and keep track of trial status.
• Assist in quality assurance/quality control activities to ensure accuracy and completeness of clinical trial data
• Maintain and utilize sound working knowledge of all program regulations, standards and policies; keep current with all relevant federal, state and local regulations, recalls, and guidance as relevant to assigned work areas
• Assist in creation, maintenance and updating work instructions, guidance documents in assigned program areas and work tasks
• Participate with direct supervisor, OCRST and other Cancer Center departments and staff to identify and implement ways to improve data reporting practices, procedures, and workflows.

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.

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

Equal Opportunity Employer:

The University of Colorado (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 workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, Information Technology, Data Sciences, or other related discipline
• One (1) year clinical, research, or data reporting experience

Substitution: Work experience in clinical, research or data reporting field can substitute for the degree on a year for year basis.

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

• Experience working in a CTMS, preferably OnCore
• Familiarity with ClinicalTrials.gov and pertinent federal regulations
• Data management and quality assurance working experience in a similar role at a similar level
• Experience in problem solving and/ or process improvement strategies
• Oncology clinical research and/or data reporting experience
• Data management and quality assurance working experience in a similar role at a similar level
• Experience writing Standard Operating Procedures (SOP) and Guidance Documents

Knowledge, Skills and Abilities:

• Knowledge of oncology, clinical research, and medical terminology
• Attention to detail and ability to work within complex data sets
• Self-motivated and directed, with keen attention to detail
• Excellent interpersonal, communication, organizational, and problem solving skills
• Ability to collaborate effectively in a team environment
• Proficient in Microsoft Word, Excel, and Outlook, familiar with Microsoft Access
• Ability to work independently and manage priorities so that projects are completed efficiently and effectively.
• Ability to communicate effectively and with a high level of professionalism across various stakeholders including physicians, clinical research staff, and health care staff

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: Sarah Thompson, sarah.e3.thompson@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by June 11, 2025. 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).

Intermediate: $52,721-67,061

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 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:

The University of Colorado (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 workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply.

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.