Job Overview

In collaboration with the QA Manager and the Education Manager, implement education and training offerings for clinical research professionals (CRCs, Data-OBCs, Regulatory, QA, Investigators) and physicians/medical staff working in oncology human subject research studies (Phase I-IV studies across all disease sites). Actively participate, plan, and evaluate multiple complex and/or multi-faceted research programs for one or more designated departments, programs, or central units. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.

Essential Functions

• Provide general onboarding for all new clinical research hires (clinical research coordinators, regulatory, data, coordinators, etc.) for all disease groups. Prepare agendas for training, onboarding materials, ensures access to resources (Canvas, EPIC, Complion, SignalPath, etc.) and schedule initial and follow-up meetings as required.
• Maintain the UCCC CTO Canvas & REDCap education and training platforms, create and update educational content and quizzes in collaboration with the Education Manager and QA Manager.
• Maintain documentation of routine training for CTO Staff and Investigators (CITI, GCP, SOPs, Workflows, Policies etc.) and ensure timely notices for renewals are issued. Maintain documentation of training for educational sessions and workshops as they arise.
• Develop and maintain repositories for all internal policies and workflows in collaboration with the QA Manager. Perform annual reconciliations of internal workflows for compliance with current research practices, institutional standards, and office needs. Update policies, workflows, SOPs etc. in real-time as applicable and disseminate to CTO or external stakeholders.
• Collaborate with the QA Data Project Manager to obtain metrics from onboarding systems or from survey data from educational offerings. Prepare reports in collaboration with the Education Manager.
• Assist with coordinating obtaining continuing education credits for internal education offerings.
• Serve as a resource to site personnel for questions on ICH-GCP, ALCOAC, NCI requirements, FDA human subject regulations, and local SOPs/workflows/guidelines.
• May provide in-person instruction in clinical settings on oncology research best practices and CTO expectations (e.g., obtaining informed consent, documenting source in the EMR per ICH-GCP, working with stakeholders in pharmacy/infusion/lab etc.) to research staff and clinicians.
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Bachelor's Degree
• Six (6) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Two (2) years of related experience.

Additional Qualifications Considered

• Experience in an academic or clinical setting.
• SOCRA or ACRP certification.

Physical Requirements/Work Environment