• Design and review study protocols and participant documents in collaboration with principal investigators, sponsors, and CROs.• Develop budgets in collaboration with budget specialists.• Develop specimen and procedure requisitions in collaboration with ancillary departments.• Review and route contracts and legal agreements.• Manage regulatory submissions such as COMIRB, WIRB, University of Colorado Cancer Center Protocol Review and Monitoring System, OnCore.• Facilitate review of site documents by external IRBs.• Secure approval from manufacturer, FDA, and local institution for single-patient IND. • Recruit and consent subjects for clinical research studies.• Supervise collection of biological samples and questionnaire data from participants.• Medical record review for confirmation of diagnosis, medications, adverse events, etc.• Review and approve study billing in EPIC.• Make travel arrangements for study subjects.• Subject reimbursement via gift card and the Greenphire system.• Data entry in REDCap and eCRF systems used by sponsors.• Maintain investigator and staff training and regulatory compliance. • Create and maintain study binders (regulatory and patient binders).• Perform all tasks in compliance with HIPAA and ICH GCP guidelines.

• Design study protocols and participant documents in collaboration with principal investigators.• Manage regulatory submissions such as Colorado Multiple IRB, Children’s Hospital Colorado Research Institute, Colorado Clinical and Translational Sciences Institute.• Recruit and consent subjects for translational research studies.• Supervise collection of biological samples and questionnaire data from participants.• Medical record review for confirmation of diagnosis, medications, etc.• Review and approve study billing in EPIC.• Longitudinal follow up and subject reimbursement.• Database design and management.• Maintain investigator and staff training and regulatory compliance. • Coordinator at lead site for multi-site study.• Manuscript preparation.