"Tissue Bank Coordinator (GI Team)"

Tissue Bank Coordinator (GI Team)

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Tissue Bank Coordinator (GI Team)

Position #: 00737533 - Requisition #: 39396

Job Summary:

The primary focus of this position is to manage and coordinate the day-to-day operations of a pancreatic tissue banking study, ensuring all protocol-driven activities-including patient screening and consent, biospecimen collection and processing, and accurate research documentation-are completed in compliance with institutional and regulatory requirements. This role collaborates closely with investigators, clinical partners, and research staff to support high-quality biospecimen workflows, maintain audit-ready records, and uphold the scientific integrity of clinical research activities. In addition to leading pancreatic tissue banking operations, the position provides data entry and research support for other interventional clinical trials, as assigned. Work performed in this role supports the Cancer Center's mission to improve patient care and advance scientific discovery through high-quality clinical and translational research.

Key Responsibilities:

• Assist with and oversee the day-to-day operations of assigned tissue banking protocols and other studies as assigned - 20%
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial - 15%
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required - 15%
• Communicates and serves as a liaison with hospital staff, physicians, and tissue bank personnel - 10%
• Ensure and collaborate with applicable parties for collection of protocol mandated samples - 5%
• Educate potential subjects on the details of the studies through phone contacts and personal interviews - 3%
• Adheres to research regulatory standards - 2.5%
• Maintain 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 - 3%
• Participates in quality assurance efforts as well as DSMC audits - 2%
• Participates in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities - 5%
• Ensures accurate and timely data entry of tissue bank patient data and other clinical trial data as assigned - 10%
• Meet with Monitors to respond to any question of data validity and correct/revise data as appropriate; respond to queries from Sponsor - 2.5%
• Assist with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses - 1%
• Ensure that the necessary supplies and equipment for studies are in stock and in working order - 1%
• Schedule, coordinate, and prepare for Sponsor Monitor Visits and audits in collaboration with the CCTO Regulatory Affairs, Primary CRC and other research team members - 5%

Intermediate Level, all the above and:

• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• 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

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) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Assist in study expansion and ongoing support to other sites

This description is a summary only and describes 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:

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 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

Qualifications:

Minimum Qualifications:

Entry Level (level I - Entry)

• Bachelor's degree in any field

Intermediate Level (level II - Intermediate)

• Bachelor's degree in any field
• One (1) year clinical research experience

Senior Level (level III - Senior)

• Bachelor's degree in any field
• Two (2) years' clinical research experience

Substitution (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

Applicants must meet minimum qualifications at the time of application.

Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Preferred Qualifications:

• Bachelor's degree in science or health related field
• One (1) year of clinical research or related experience
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Additional certification (one of the following):
  • CCRC - Certified Clinical Research Coordinator
  • CCRP - Certified Clinical Research Professional
  • CCRA - Certified Clinical Research Associate

Knowledge, Skills and Abilities:

• Knowledge and understanding of federal regulations 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

Anticipated Pay Range:

• Entry: $48,446 - $61,623
• Intermediate: $52,721 - $67,061
• Senior: $56,995 - $72,498

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