DSMC Auditor (Open Rank)
About the position This full-time position will assist with the implementation and coordination of the auditing program as outlined by the CU Cancer Center’s NCI-approved Institutional Data Safety Monitoring Plan to assure the highest quality, safest, and most precisely performed clinical cancer research. Key Responsibilities: Examples of Work Performed by the Clinical Research Auditor (all levels): · Ensures clinical trials at both internal and external sites subject to CU Cancer Center oversight are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) & Code of Federal Regulations. · Assures adherence to all research standards set forth by the International Council on Harmonization (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies and adheres to institution SOPs. · Audits National Clinical Trial Network (NCTN), Investigator-Initiated (IITs) and Industry sponsored clinical trial protocols. · Applies knowledge of protocol design to assess the conduct of the protocol and evaluate trials for any protocol deviations and escalate unacceptable findings. · In collaboration with the DSMC Manager, participates in the creation, research, and conduct of process and quality improvement projects. Examples of Work Performed by Level II (Senior Professional) · Provides audit shadowing for new auditors, reviews and helps develop DSMC and CU Cancer Center level SOPs, Guidance Documents, and Work Instructions. · Provides feedback and examples to foster collaboration with the Oncology Clinical Research Support Team (OCRST) Monitoring Manager to ensure consistent communication and facilitate escalation between the monitoring and auditing teams. · Acts as a resource for Investigators and their teams including answering questions, advising on corrective/preventative action, root cause analysis, clarifying requirements, resolving problems, etc. Examples of Work Performed by Level III (Principal Professional) Acts as the subject matter expert for clinical trials under the purview of the DSMC. Assists the DSM Manager in training new auditors. · Assists the DSMC Chair and the DSM Manager on strategic research objectives and evaluation benchmarks Responsibilities • Ensures clinical trials at both internal and external sites subject to CU Cancer Center oversight are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) & Code of Federal Regulations. • Assures adherence to all research standards set forth by the International Council on Harmonization (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies and adheres to institution SOPs. • Audits National Clinical Trial Network (NCTN), Investigator-Initiated (IITs) and Industry sponsored clinical trial protocols. • Applies knowledge of protocol design to assess the conduct of the protocol and evaluate trials for any protocol deviations and escalate unacceptable findings. • In collaboration with the DSMC Manager, participates in the creation, research, and conduct of process and quality improvement projects. • Provides audit shadowing for new auditors, reviews and helps develop DSMC and CU Cancer Center level SOPs, Guidance Documents, and Work Instructions. • Provides feedback and examples to foster collaboration with the Oncology Clinical Research Support Team (OCRST) Monitoring Manager to ensure consistent communication and facilitate escalation between the monitoring and auditing teams. • Acts as a resource for Investigators and their teams including answering questions, advising on corrective/preventative action, root cause analysis, clarifying requirements, resolving problems, etc. • Acts as the subject matter expert for clinical trials under the purview of the DSMC. • Assists the DSM Manager in training new auditors. • Assists the DSMC Chair and the DSM Manager on strategic research objectives and evaluation benchmarks Requirements • Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a related field from an accredited institution. • One year of clinical research experience. • One year of experience auditing or monitoring clinical trials. • At least two (2) years of experience auditing or monitoring clinical trials. • Must possess a current and valid driver’s license and/or reliable transportation for in-person audits. • Be willing to travel for out-of-state audits (very rare). • Knowledge of basic human anatomy, physiology, and