Start-Up Specialist (Senior)

Job Summary:

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.

Key Responsibilities:

• Serves as main study contact person for the entire CCTO department for new/ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
• Collaborate with sponsor at a high level to cultivate and expand upon existing relationships.
• Coordinate and attends site qualification visits for multiple disease sites.
• Completes feasibility questionnaires for multiple disease sites.
• Tracks new and declined studies across 10+ disease sites.
• Completes prioritization documents for PRMC across 10+ disease sites.
• Submits CDAs for review/negotiation across 10+ disease sites.
• Participates in Data Safety Monitoring Committee (DSMC) activities.
• Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents through ongoing training.
• Negotiates for increasing use of internal resources in order to utilize institutional assets that could result in higher efficiency and quality.
• Serves as direct liaison with budget and finance, assisting in escalations of contract and budget negotiation with sponsors and CROs.
• Serves as a direct liaison with sponsor/CRO medical monitors.
• Facilitates Pipeline Discussions with sponsor/CRO's across 10+ disease sites.
• Takes responsibility for meeting internal and external timelines.
• Attends clinical team meetings and SIV visits as necessary.
• Assists in escalation of sponsor and CRO related concerns and communication issues.
• Manages Sponsor Information Portals.
• Serves as back-up to budget assistants for CDA routing across 10+ disease sites.

Work Location:

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

Why Join Us:

Use your college/unit or department as a selling point. Think about the "what's in it for me" candidate viewpoint. You do not need to include everything, just the most appealing parts of working for your college/unit or department. Keep this section short and concise for effectiveness - in general, try to limit it to 1-2 paragraphs.

Benefits statement to include in all benefits-eligible positions:

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:

Education: BS or BA in Biology, Chemistry, Physiology, Behavioral Sciences, Nursing, Business Administration, Accounting, Human Biology, Public Policy, Communications, Psychology, or Public Health or related field

Experience: A minimum of 2 years clinical research experience

Substitution: A combination of education and experience can substitute for the degree on a year-for-year basis.

Certification & Licensure Required: Current HIPPA and GCP training; Current Clinical Research Certification (CCRC, CCRA, CCRP) - and/or eligible and willing to sit for next available exam. Must have certification within one year of employment. Failure to complete the certification requirement within one year may be cause for termination.

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

• Two (2) years' oncology experience (clinical or research)
• Four (4) years' clinical, research or clinical research experience
• Experience working with Cancer Therapy Evaluation Program and PI initiated studies
• Experience working in an academic medical setting
• Experience in teaching, precepting and mentoring employees to clinical research
• Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology

Knowledge, Skills and Abilities:

• Excellent interpersonal communication, organizational skills, and ability to solve problems and multi-task
• Understands 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.

• Demonstrates the quick ability to learn, interpret and master complex protocol information.
• Knowledge of study budgets and contracts.
• Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications.
• Possesses advanced knowledge of Good Clinical Practices, 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.

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: Mark Morrow, mark.morrow@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 24, 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).

Level III (Senior) $56,995

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.