DSMC LAPS Auditor

DSMC LAPS Auditor - 22510University Staff Description

University of Colorado | CU Anschutz Medical Campus

School of Medicine, Cancer Center

Data Safety Monitoring Committee

Research Services Senior Professional (Senior Professional or Principal Professional – Open Rank)

Auditor (Auditor or Senior Auditor – Open Rank)

Position #708214 Requisition #22510

This position can be done approximately 50% remotely

The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.

The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.

The CU Cancer Center’s vision is to “prevent and conquer cancer. Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”

The Data and Safety Monitoring Committee (DSMC) at the University of Colorado Cancer Center is seeking to employ a full time Clinical Research Auditor. Depending on qualifications and department needs, appointments may be made at the Auditor or Senior Auditor level.

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. This position will focus primarily on trials conducted by the National Clinical Trial Network (NCTN) as part the CU Cancer Center’s Lead Academic Participating Site (LAPS) Grant.

Examples of Work Performed by the Clinical Research Auditor (all levels):

• Assures adherence to all research standards set forth by the International Council on Harmonisation (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 Standard Operating Procedures.
• 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 (GCPs) & Code of Federal Regulations.
• Audits primarily National Clinical Trial Network (NCTN) but will also audit Investigator-Initiated (IITs) and Industry sponsored clinical trial protocols:
  • Applies knowledge of protocol design to assess conduct of protocol
  • Develops timeline for audits & schedules review activities
  • Verifies clinical trial source documentation & CRF data (as applicable)
  • Reviews regulatory documentation
  • Performs drug accountability
  • Evaluates trials for any protocol deviations
  • Authors final audit report
  • Communicates audit results to management & teams
  • Maintains correspondence with Principal Investigators & teams
  • Manages audit activities & follows up on any corrective/preventive actions
  • Escalates unacceptable findings
  • Identifies and remedies areas of non-compliance
  • Tracks and analyzes clinical data for safety trends
  • Trains and educates Cancer Center research staff through audit activities
• Evaluates CU Cancer Center quality systems, processes, procedures, and protocols for safety and compliance based on regulations and participates in developing corrective and preventative action plans as appropriate.
• Reviews and develops DSMC and CU Cancer Center level SOPs, Guidance Documents and Work Instructions.
• Rare travel within or out of state may be required for auditing activities on multicenter IITs
• Educates Cancer Center research staff.

Examples of Work Performed by Senior Auditor:

• Acts as the subject matter expert for all clinical trials under the purview of the DSMC.
• In collaboration with the DSMC Director, participates in the creation, research and conduct of process and quality improvement projects.
• Serves as trainer for new auditors.
• Assists the DSMC Chair and Director on strategic research objectives and evaluation benchmarks.
• Maintains department audit schedule and audit prioritization.
• Provides audit support for DSMC auditors.
• Liaisons with OCRST Monitoring Manger to ensure consistent communication and facilitate escalation between monitoring and auditing team.
• Acts as a resource for investigators and their teams (this includes answering questions, advising on corrective/preventative action, root cause analysis, clarifying requirements, resolving problems, etc.).
• Support the facilitation and execution of DSMC Meetings.

Professionals in this career family are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed independently.

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Salary and Benefits:

The salary range (or hiring range) for the Auditor level has been established at $51,564 -$65,590, and the Senior Auditor level has been established at $59,299 - $70,453, commensurate with skills and experience.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Qualifications

Minimum Qualifications:

Auditor Level:

• Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a directly related field from an accredited institution.
• Two years of clinical research experience.
• Experience auditing or monitoring clinical trials. For this position, monitoring is defined as a quality control function that ensures the protection of research subjects and verifies the completeness and accuracy of trial data in real time. Auditing is defined as a quality assurance function, which is independent and separate from routine monitoring and evaluates a trial’s conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements.

Substitution: A combination of education and related technical/paraprofessional work experience may be substituted for the bachelor’s degree on a year for year basis, but not for the required clinical research experience.

Senior Auditor Level:

• Bachelor’s degree in nursing, biology, chemistry, public health, public administration, social/behavioral sciences, business or a directly related field from an accredited institution.
• Three or more years of professional and progressively responsible clinical research experience.
• At least one year of experience auditing or monitoring clinical trials. For this position, monitoring is defined as a quality control function that ensures the protection of research subjects and verifies the completeness and accuracy of trial data in real time. Auditing is defined as a quality assurance function, which is independent and separate from routine monitoring and evaluates a trial’s conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements.

Substitution: A combination of education and related technical/paraprofessional work experience may be substituted for the bachelor’s degree on a year for year basis, but not for the required clinical research experience.

Conditions of Employment:

• Must possess a current and valid driver’s license and reliable transportation for audits.
• Be willing to travel up to 25% including out of state and possible overnight trips.

Conditions of Employment for Auditor Level:

• Must possess OR obtain within 1 year of employment a current and valid Clinical Research Certification (i.e., Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP-CP), or Certified Clinical Research Associate (CCRA)).

Conditions of Employment for Senior Auditor Level:

• Must possess a current and valid Clinical Research Certification (i.e., Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP or ACRP-CP), or Certified Clinical Research Associate (CCRA)).

Preferred Qualifications:

• Four (4) or more years of clinical research experience
• Oncology Clinical Research experience
• Prior experience working at an Academic Medical Center’s DSMC or DSMB
• Active Colorado RN license
• Knowledge of NCI Toxicity and Tumor Evaluation Criteria
• Experience working on CAR T or other immunotherapy/adoptive cell therapy trials
• Experience working with quality assurance and quality control/monitoring of clinical trials
• Experience developing SOPs

Knowledge, Skills and Abilities:

• Knowledge of basic human anatomy, physiology medical terminology as well as Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, 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 level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains 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 is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
• Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, 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.

Special Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Application Materials Required: Cover Letter, Resume/CV, List of References Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Applications will be accepted until finalists are identified, but preference will be given to complete applications received by [10 days]. Those who do not apply by this date may or may not be considered.
Job Category: Research Services Primary Location: Aurora Department: U0001 - DENVER & ANSCHUTZ MED CAMPUS - 20066 - SOM-U of Colo Cancer Center Schedule: Full-time Posting Date: Sep 3, 2021 Unposting Date: Ongoing Posting Contact Name: Lara Sprague Posting Contact Email: lara.sprague@cuanschutz.edu Position Number: 00708214