Associate Clinical Research Coordinator - Oncology Group Center Cancer and Blood Disorders

Associate Clinical Research Coordinator - Oncology Group Center for Cancer and Blood Disorders

Benefits include vision insurance, parental leave, paid time off, 403(b) retirement plan, and remote work opportunities.

The Clinical Research Coordinator Associate is responsible for participating in the day-to-day operations of routine, minimally complex clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Supports the achievement of research program and/or study objectives.

Works under close supervision, receiving instruction, guidance and direction from Senior CRC, Clinical Research Supervisor and/or leadership team.

We are looking for a motivated, detail-oriented, highly organized, team-oriented person to join our Children's Oncology Group research team in the Center for Cancer and Blood Disorders (CCBD). The Children's Oncology Group (COG) is a cooperative group specializing in pediatric clinical research inclusive of children, adolescents and young adults with cancer. The COG partners with research scientists from around the world in efforts to understand the causes of cancer and find more effective treatments for the children we care for.

Today, more than 90% of 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. COG's unparalleled collaborative efforts provide the information and support needed to answer important clinical questions in the fight against cancer. The Children's Oncology Group has nearly 100 active clinical trials open at any given time.

These trials include front-line treatment for many types of childhood cancers, studies aimed at determining the underlying biology of these diseases, and trials involving new and emerging treatments, supportive care, and survivorship. The Children's Oncology Group research has turned children's cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today.

Our extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

Hours per week: 40, eligible for benefits. Shift times: , , , . May require occasional weekend and holiday coverage.

This position may allow for the occasional opportunity to work from home. This is dependent upon the successful completion of department on-boarding/training, offsite workload and job performance/competence.

• Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol.
  
  Assists with the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies identifies issues recommends solutions.
• Regulatory - Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Study Participation - Screens, schedules, consents participants in assigned clinical research programs and/or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies.
  
  Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Protocol - Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all assigned regulatory and organizational protocols. Trains in completing and submitting AE reports, according to institution and sponsor-specific reporting requirements. Assists with the development of proposals or protocols as directed.
  
  Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• Human Subject Research Protection - Maintains compliance with…