OCRST Research Monitor
*Applications are accepted electronically ONLY at www.cu.edu/cu-careers.*
University of Colorado Denver l Anschutz Medical Campus
School of Medicine | University of Colorado Cancer Center
OCRST Research Monitor (Research Services Senior Professional)
Position #728829 - Requisition 12613
The University of Colorado Cancer Center has an opening for a full-time, University Staff (unclassified) OCRST Research Monitor (Research Services Senior Professional) position.
The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.
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.
This position will assist with the implementation and coordination of the Oncology Clinical Research Support Team (OCRST) Investigator Initiated Trials (IITs) Program at the University of Colorado Cancer Center by participating in protocol development and data monitoring activities. This position will collaborate with other OCRST members, sponsor-investigators and clinical research teams to ensure compliance in protocol conduct, patient safety and data integrity for IITs assigned. Data monitoring will include verification of the accuracy, completeness, validity & integrity of all data collected. This position will identify need for and assist in writing policies, procedures or other documentation to support monitoring activities in the Cancer Center.
Examples of Work Performed:
- Assures adherence to all research standards as set forth by the 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, plus adheres to institution Standard Operating Procedures.
- Schedules and coordinates the activities of the Monitoring Program for Investigator Initiated and National Clinical Trials Network trials; conducts the monitoring reviews of the trials including issuing data clarification queries as necessary.
- Writes monitoring reports and communicates monitoring results to OCRST management, teams, including PIs and forwards results to DSMC for review.
- Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to OCRST Monitoring Manager and Program Director as appropriate.
- Ensures that written procedures are followed and evaluates quality systems, processes, procedures, and protocols for safety and compliance.
- Participates in developing SOP's, guidance documents or other tools/templates pertinent to monitoring activities.
- Assists Cancer Center Principal Investigators in the development of local Investigator Initiated projects by participating in review of protocols for inclusion of relevant data monitoring language.
- Collaborates with OCRST and other Cancer Center departments and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.
- Work with the education and development coordinator, as well as the sponsor-investigators on training of CRC and data management staff during site initiation visits and based on topics noted from monitor visits.
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.
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Salary and Benefits:
The hiring salary for this position is 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 science, nursing, health, public health or other related discipline from an accredited institution.
- Two (2) years of clinical research experience.
- Experience with monitoring clinical trials. For this position, monitoring is defined as a quality control function that ensures the protection of research subjects, verifies the completeness and accuracy of trial data and establishes that the trial was conducted in accordance with the protocol, GCP, and pertinent regulations at the clinical trial site in real time.
Substitution: Clinical research or monitoring experience can substitute for the degree on a year for year basis, but not for the specific experience.
Conditions of Employment:
- Occasional travel within or out of state is required for monitoring activities on multicenter IITs.
- Quality Assurance, Quality Control or Monitoring experience.
- Three (3) or more years of clinical research experience.
- Oncology research experience.
- Experience working with investigator initiated research.
- Experience working in an academic setting.
Competencies/Knowledge, Skills and Abilities:
- Ability to problem solve and multi-task.
- Excellent computer skills. Proficient in Windows, MS Word, Excel.
- Possesses 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.
- Possesses an understanding of the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
- Knowledge of basic human anatomy, physiology, medical terminology.
- Ability to communicate effectively and with a high level of professionalism across various stakeholders.
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
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) Questions should be directed to: Lisa.M.Carter@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 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 February 23, 2018. Those who do not apply by February 23, 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: Feb 9, 2018
Closing Date: Ongoing
Posting Contact Name: Lisa Carter
Posting Contact Email: Lisa.M.Carter@ucdenver.edu
Position Number: 00728829