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Professional Research Assistant

Employer
University of Colorado Anschutz Medical Campus
Location
Denver, CO

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Administrative Jobs
Academic Affairs, Research Staff & Technicians
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Job Details

Description

University of Colorado – School of Medicine

Professional Research Assistant

 

The University of Colorado Denver l 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 Department of Orthopedics, Sports Medicine has an opening for a full time Professional Research Assistant (PRA). The PRA will serve as the Research Coordinator/Regulatory Manager for clinical trials and will report to Dr. Jason L. Dragoo, Professor for the Department of Orthopedics.

This position will assist faculty with all aspects of administrative activities related to the submission of Institutional Review Board (IRB) protocols to the Colorado Multiple Institutional Review Board (COMIRB), Western IRB (WIRB), and other regulatory agencies. This includes protocol development, writing consent forms, adverse event reporting, and managing continuing reviews of protocols. The PRA will ensure compliance with all internal and external policies and procedures that govern the department's human subject research. This includes monitoring FDA-IDE and NDA trials and maintaining compliance with Clintrials.gov.

The PRA will interact with patients during study visits and ensure completion of all necessary documentation, as well as facilitating study-related billing. The PRA will serve as a liaison to study sponsors and will lead site visits. The PRA will al so assist in the development and maintenance of a record keeping system of protocols for COMIRB and other regulatory agency activities.

Duties include, but are not limited to:

  • Monitor on-going research projects on a daily basis
  • Maintain complete records of all research projects
  • Track upcoming patient study visits
  • Assist in design and submission of future research protocols
  • Submit and maintain institutional review board for protocols
  • Interact with sponsors regarding clinical studies
  • Interact with patients during study visits
  • Maintain database of clinical studies
  • Assist with preparation of manuscripts and research presentations
  • Assist with preparation of grants and project reports
  • Provide additional support to the Principal Investigators as needed
Knowledge, Skills, and Abilities

  • Excellent knowledge regarding IRB policies and procedures
  • Excellent knowledge regarding Sponsor and FDA regulatory requirements
  • High attention to detail
  • Ability to maintain confidentiality and professionalism with patients
  • Excellent communication skills, both written and verbal
  • Ability to problem solve and multi-task
  • Good command of the English language, both written and verbal
  • Excellent computer skills
Salary Range

The salary range (or hiring range) has been established at $42,000 to $50,000.

 

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

 

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 checks for all new employees prior to their employment.

 

The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.

 

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: https://www.cu.edu/employee-services/total-compensation

 

Diversity and Equity:

 

Please click here for information on disability accommodations: https://www1.ucdenver.edu/offices/human-resources/employee-relations-performance/ada-compliance

 

Office of Equity: https://www1.ucdenver.edu/offices/equity

 

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.



Qualifications
Minimum Requirements

  • Bachelor's degree in a related field
Applicants must meet minimum qualifications at the time of hire.

 

Preferred Qualifications

  • Minimum one year experience with clinical trials management
  • Master's degree in health-related field
  • Experience with SPSS, SAS, Stata and REDCap, Excel, EndNote
  • Experience with peer-reviewed manuscript reparation


Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jun 15, 2021
Unposting Date: Ongoing
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