Clinical Trial Data Support Specialist

Job description

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, The Cancer Center

Clinical Trial Data Support Specialist (Research Services Professional)

Position #708329 – Requisition #20913

* 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) Clinical Trials Data Support Specialist 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.

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 coordinating QA/QC activities, acquiring and tracking staff and investigator credentials, NCTN support, and providing data support for the Cancer Center Support Grant (CCSG) and other clinical research operations. This position is also responsible for registering and managing data within the Clinicialtrials.gov and Clinical Trial Reporting Program (CTRP) databases. This position will be required to collaborate across UCCC Clinical research teams, investigators and consortium member sites to fulfill reporting requirements and to support reporting for Cancer Center Support Grant (CCSG), the Lead Academic Participating Site (LAPS) U10, and the NCI Early Phase I and Phase II UM1 grants.

Examples of Work performed

  • Ensure timely registration of new 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 ensure compliance with regulatory requirements; identify and resolve 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.
  • Notify PI when study results are due in Clinicaltrials.gov and follow up to ensure this has been completed.
  • Monitor data to identify problems and /or inconsistencies in trials and patient enrollment data to those trials; recommend corrective action as appropriate.
  • Collaborate with clinical research team members across the UCCC 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 keep track of trial status.
  • Participate in CTRP and CT.gov Taskforce teleconferences as needed to be compliant.Collaborate with Cancer Center leadership to support reporting on sponsored research programs including but not limited to the Cancer Center Support Grant (CCSG), the Lead Academic Participating Site (LAPS) U10, and the NCI Early Phase I and Phase II UM1 grantsAssist in quality assurance/quality control activities to ensure accuracy and completeness of clinical trial dataManage UCCC investigator and staff credentials on a monthly basisSupport the NCTN Start-up Coordinator by managing initial and renewing NCI profiles to be signed and completed, facilitating CTEP registration for new hires (staff and investigators), providing data support, and sending out study activations from the CTSU database.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.


Qualifications
Knowledge, Skills and Abilities

  • Knowledge of basic human anatomy, physiology, and medical terminology
  • Knowledge of oncology, clinical research, and medical terminology and CTMS, preferably OnCore
  • Attention to detail and ability to work within complex data sets
  • 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
  • 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 stakeholder
  • Attention to detail and ability to work within complex data sets
  • Excellent verbal and written communication skills
  • Knowledge of clinical research terminology
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 (1) 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.

Required: Applicants must meet minimum qualifications at the time of hire.

Preferred Requirements

  • Experience with oncology medical terminology and CTMS, preferably OnCore
  • Data management and quality assurance working experience in a similar role at a similar level
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 starting salary range for this position begins at $46,609 and is commensurate with skills and experience.

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

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 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.

 



Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Apr 26, 2021
Unposting Date: Ongoing

 

 

 

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Job No:
Posted: 4/17/2021
Application Due: 5/26/2021
Work Type: Full Time
Salary: