University of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center
Research Services Intermediate Professional (ClinicalTrials.Gov and CTRP Coordinator)
Position #708329 – Requisition #19869
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers
The Cancer Center has an opening for a full-time University Staff (unclassified) ClinicalTrials.Gov and CTRP Coordinator position.
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. at http://https://www.cuanschutz.edu/docs/librariesprovider15/default-document-library/2019-facts-brochure_web.pdf
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.”
Nature of Work
This position will participate as a member of the Cancer Center’s Oncology Clinical Research Support Team (OCRST) and is responsible for ensuring compliance with the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP) and the FDA’s ClinicalTrials.gov reporting requirements. The purpose of CTRP is to have a central repository of registration, accrual, and outcome information for clinical trials conducted in NCI-designated cancer centers. The purpose of ClinicalTrials.gov is to provide information that is available to the public about clinical research studies. This information contains summary information about clinical studies being conducted throughout the United States and the world. The incumbent will be responsible for registering appropriate trials to CTRP and clinicaltrials.gov, and ensuring ongoing reporting requirements are met for trial status and accrual. This position will be required to collaborate across CU Cancer Center Clinical research teams, investigators and consortium member sites to fulfill reporting requirements.
Data Entry and Reporting
Quality, Education, and Outreach Manager (Amanda Kinderman)
Examples of Work performed
Ensure timely registration of investigator initiated clinical trials into CTRP and ClinicalTrials.gov.
Aggregate and review clinical data including research protocols, regulatory documents and other documents related to CTRP and ClinicalTrials.gov from a variety of sources ensuring accuracy, timeliness, confidentiality, and security of data.
Track outstanding submissions to insure compliance with regulatory requirements and identifying and resolving problems that could interfere with meeting submission requirements. This also includes prompt recognition and appropriate referral of problems that require escalation.
Review CTRP’s trial summary reports (TSRs) and ensure the quality of abstractions by cross-checking data and verifying content from source documents for accuracy.
Maintain existing clinical trials in CTRP and ClinicalTrials.gov including trial status updates and amendments.
Timely submission of quarterly accruals into CTRP on all applicable trials.
Collaborate with Clinical Research team members across the CU Cancer Center Consortium to assure needed regulatory data and subject enrollment data is collected accurately and in a timely manner.
Monitor notifications and reports from OnCore to track new trials and manage trial status changes for CTRP and Clinicaltrials.gov.
Maintain data sources that are used to verify CTRP and ClinicalTrials.gov current and historical entries for accuracy and completeness.
Provide education and training to study teams in order that they develop an understanding of regulations and requirements for clinical trials registration.
Maintain oversight of all CU Cancer Center records to assure timely updates by study teams and timely entry of results data as required by the regulations.
Develops standard operating procedures, education materials, tip sheets and other documents as required.
Maintains current knowledge of status of regulatory requirements for submission and maintenance of clinical trials registration.
Participate in CTRP and CT.gov Taskforce teleconferences as needed to be compliant.
Participate with OCRST and other Cancer Center departments and staff to identify and implement ways to improve data reporting practices, procedures, and workflows.
Willingly accepts additional responsibilities and duties as assigned by management. Performs other related duties and procedures, including special projects, as directed
Salary and Benefits:
The salary range (or hiring range) for this position has been established at $46,609 - $50,000 .
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 at https://www.cu.edu/employee-services/benefits-wellness
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 email@example.com.
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.
Bachelor’s degree in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, Information Technology, Data Sciences, or other related discipline
One-year clinical, research, or data reporting experience.
Substitution: Work experience in clinical, research or data reporting field can substitute for the degree on a year for year basis.
Previous experience with Clinical Trials.gov and the requirements of FDAAA and FDAMA
Previous experience in the CTRP database
Previous experience with OnCore
Data management and quality assurance working experience in a similar role at a similar level
Knowledge, Skills and Abilities
Knowledge of basic human anatomy, physiology, oncology, clinical research, and medical terminology
Self-motivated and directed, with keen attention to detail
Excellent interpersonal, communication, organizational, and problem solving skills
Ability to work independently and manage priorities
Ability to collaborate effectively in a team environment
Attention to detail and ability to work within complex data sets
Knowledge of the regulations governing clinical trials registration and the ability to handle time sensitive documents and maintain strict a tight time line for completion of registration
Proficient in InfoEd, ClinicalTrials.gov registration system, and CTRP registration and accrual system
Proficient in Microsoft Word, Excel, and Outlook, familiar with Microsoft Access
Ability to work independently and manage priorities so that projects are completed efficiently and effectively.
Ability to communicate effectively and with a high level of professionalism across various stakeholders
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.
Required: Applicants must meet minimum qualifications at the time of hire.
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Job: Research Services
Primary Location: Aurora
Job Category Research Services
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Jan 7, 2021
Unposting Date Ongoing
Posting Contact Name Amanda Kinderman
Posting Contact Email Amanda.firstname.lastname@example.org
Posting Number 00708329
Req ID: 19869
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.