ClinicalTrials.Gov and CTRP Coordinator
DescriptionUniversity 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
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.Professional Field
Data Entry and ReportingSupervision Received
Quality, Education, and Outreach Manager (Amanda Kinderman) Supervision Exercised
NoneExamples 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
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.
Total Compensation Calculator: http://www.cu.edu/node/153125Diversity 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 protected] 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.
- 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 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
Job Category: Research Services
Primary Location: Aurora
Posting Date: Jan 7, 2021
Unposting Date: Ongoing