CPDM Research Monitor
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
CDPM Research Monitor
Position # 00707667 - Requisition 09486
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The Universit of Colorado Cancer Center has an opening for a full-time University Staff (unclassified) CDPM Research Monitor position.
The University of Colorado Denver Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver-one of America's most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.
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 25 by U.S. News and World Report for cancer care and Children's Hospital Colorado is ranked 9th by the same organization. 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 400 researchers and physicians at three state universities and three clinical institutions, all working toward one goal: Translating science into life.
This position will assist with the implementation and coordination of the Clinical Protocol and Data Management (CPDM) 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 CPDM IIT team members, sponsor-investigators and clinical research teams to ensure compliance in protocol conduct, patient safety and data integrity for assigned IITs. 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 CPDM 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 CPDM Program Director.
- 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 CPDM 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.
- Occasional travel within or out of state required for monitoring activities on multicenter IITs.
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 science, nursing, health, public health or other related discipline
- Two 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: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis, but not two years of clinical research experience.
- Quality Assurance, Quality Control or Monitoring experience
- Three years' clinical research experience
- Oncology research experience
- Experience working with investigator initiated research
- Experience working in an academic setting
Knowldege, Skills, and Abilities:
- Ability to communicate effectively, both in writing and orally.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
- 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
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 Stacy Grolnic at email@example.com
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 3-5 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 May 26, 2017 Those who do not apply by May 26, 2017 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 5, 2017
Closing Date: Ongoing
Posting Contact Name: Stacy Grolnic
Posting Contact Email: Stacy.Grolnic@ucdenver.edu
Position Number: 00707667