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 medical terminology.
• Working knowledge of Good Clinical Practice (GCP), FDA Rules and Regulations for clinical trials, NIH guidelines, ICH guidelines, clinical trial HIPAA regulations, and NCI common toxicity definitions.
• Analytical Skills - Ability to interpret and master complex research protocol information.
• Attention to Detail – Work is accurate, and details are not overlooked.
• Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
• Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all levels; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains a high level of confidentiality.
• Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
• Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Adaptability – Adapts quickly to change and can manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; can work independently and as part of a team.
• Planning and Organizing – Sets priorities, anticipates obstacles when planning, manages time effectively to accomplish tasks.
• Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
Nice-to-haves
• At least two years of clinical research experience
• Oncology clinical research experience
• Clinical research regulatory experience
• Prior experience auditing clinical research at an Academic Medical Center
• Knowledge of NCI Toxicity and Tumor Evaluation Criteria
• Experience working on CAR T or other immunotherapy/adoptive cell therapy trials
• Experience developing Guidance Documents and SOPs
• Clinical Research Certification (i.e., Certified Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP CP), or Certified Clinical Research Associate (CCRA))
Benefits
• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service
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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 medical terminology.
• Working knowledge of Good Clinical Practice (GCP), FDA Rules and Regulations for clinical trials, NIH guidelines, ICH guidelines, clinical trial HIPAA regulations, and NCI common toxicity definitions.
• Analytical Skills - Ability to interpret and master complex research protocol information.
• Attention to Detail – Work is accurate, and details are not overlooked.
• Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
• Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all levels; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains a high level of confidentiality.
• Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
• Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Adaptability – Adapts quickly to change and can manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; can work independently and as part of a team.
• Planning and Organizing – Sets priorities, anticipates obstacles when planning, manages time effectively to accomplish tasks.
• Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
Nice-to-haves
• At least two years of clinical research experience
• Oncology clinical research experience
• Clinical research regulatory experience
• Prior experience auditing clinical research at an Academic Medical Center
• Knowledge of NCI Toxicity and Tumor Evaluation Criteria
• Experience working on CAR T or other immunotherapy/adoptive cell therapy trials
• Experience developing Guidance Documents and SOPs
• Clinical Research Certification (i.e., Certified Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP CP), or Certified Clinical Research Associate (CCRA))
Benefits
• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service
Apply tot his job
Apply To this Job