Tissue Bank Coordinator (GI Team)

University of Colorado

12d•Hybrid

About The Position

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. 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.

Requirements

Bachelor’s degree in any field
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.
One (1) year clinical research experience (Intermediate Level)
Two (2) years’ clinical research experience (Senior Level)
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
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

Nice To Haves

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

Responsibilities

Assist with and oversee the day-to-day operations of assigned tissue banking protocols and other studies as assigned – 20%25
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%25
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%25
Communicates and serves as a liaison with hospital staff, physicians, and tissue bank personnel – 10%25
Ensure and collaborate with applicable parties for collection of protocol mandated samples - 5%25
Educate potential subjects on the details of the studies through phone contacts and personal interviews – 3%25
Adheres to research regulatory standards – 2.5%25
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%25
Participates in quality assurance efforts as well as DSMC audits – 2%25
Participates in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities – 5%25
Ensures accurate and timely data entry of tissue bank patient data and other clinical trial data as assigned – 10%25
Meet with Monitors to respond to any question of data validity and correct/revise data as appropriate; respond to queries from Sponsor – 2.5%25
Assist with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses – 1%25
Ensure that the necessary supplies and equipment for studies are in stock and in working order – 1%25
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%25
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
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