Clinical Research DSMC LAPS Auditor
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
Clinical Research DSMC LAPS Auditor
Position # 00708214 - Requisition 13719
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Research DSMC LAPS Auditor position.
The University of Colorado Cancer Center, located at the Anschutz Medical Campus, 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 partner for adult care, University of Colorado Hospital is ranked in the top 15 hospitals nationwide by U.S. News and World Report and Children's Hospital Colorado is ranked 8th by the same organization in Pediatric Cancer Care. 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 is a consortium of approximately 261 researchers and physicians at three state universities and three clinical institutions, all working toward its vision to prevent and cure cancer while being a global model for patient care delivery, interdisciplinary research, and training.
Nature of Work
This full time position will assist with the implementation and coordination of the Auditing Program as part of the Data and Safety Monitoring Committee (DSMC) at the University of Colorado Cancer Center for the National Clinical Trial Network's (NCTN) Lead Academic Participating Site (LAPS) Grant. This position will collaborate with various institutional stakeholders and conduct routine internal audits to assure the highest quality, safest, most precisely performed clinical cancer research.
Examples of Work Performed
- 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.
- Audits primarily NCTN clinical trial protocols but will also audit Investigator Initiated (IIT) and Industry-sponsored trials:
- Applies knowledge of protocol design to assess conduct of protocol
- Develops timeline for audits & schedules review activities
- Verifies clinical trial source & Case Report Form (CRF) documentation
- Reviews regulatory documentation
- Performs drug accountability and reviews pharmacy documentation as applicable
- Writes 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 and quality trends
- Assists in development of training and education tools for Cancer Center research staff.
- Evaluates 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 Cancer Center level SOPs, Guidance Documents and Work Instructions.
- This position will require travel to main member sites located throughout central Colorado for scheduled audits at least once annually per site and may include overnight stays.
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 hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.
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.
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.
- Bachelor's degree in nursing, biology, chemistry, health, public health or other related scientific discipline.
- Three years of clinical research experience.
- Experience with 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 three years of clinical research experience.
- Oncology research experience
- Experience working with NCTN and investigator initiated research
- Five years of clinical research experience
- Quality Assurance, Quality Control experience
- Active Colorado RN license
Knowledge, Skills and Abilities
- Working knowledge of 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.
- Ability to communicate effectively in oral and written communication.
- Ability to problem solve and multi-task. Demonstrates strength in resolving problems swiftly and independently. Must be detail oriented.
- Excellent customer service skills and is able to establish effective working relationships with employees across the institution.
- Possesses an understanding of the phases and concepts of clinical trials and the overall philosophies of conducting investigator-initiated trials as they differ with NCI sponsored, private industry and NCTN clinical trials.
- Knowledge of basic human anatomy, physiology, medical terminology and drug therapy techniques.
Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers * REQUIRED APPLICATION MATERIALS: 1). A cover letter/letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 3-5 professional references. Questions should be directed to Andrew Wise at Andrew.Wise@ucdenver.edu
Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. 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 will be accepted until the position is filled, but full consideration will be given to complete applications received by June 6, 2018. Those who do not apply by June 6, 2018 may or may not be considered.
Job Category: Research Services
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center
Posting Date: May 23, 2018
Closing Date: Ongoing
Posting Contact Name: Andrew Wise
Posting Contact Email: Andrew.Wise@ucdenver.edu
Position Number: 00708214