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University of Colorado ClinicalTrials.Gov and CTRP Coordinator in Aurora, Colorado

Description

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 University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

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. (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.

Professional Field

Data Entry and Reporting

Supervision Received

Quality, Education, and Outreach Manager (Amanda Kinderman)

Supervision Exercised

None

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 (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 hr.adacoordinator@ucdenver.edu.

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.

Qualifications

Minimum Requirements

  • 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.

Preferred Requirements

  • 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

Schedule Full-time

Posting Date Jan 7, 2021

Unposting Date Ongoing

Posting Contact Name Amanda Kinderman

Posting Contact Email Amanda.kinderman@cuanschutz.edu

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.

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