Professional Research Assistant Position University of Colorado Sports Medicine

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6 months 2 weeks ago #38807 by barandia
University of Colorado – School of Medicine

Professional Research Assistant - 20156
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.CU Sports Medicine, within the University of Colorado, Department of Orthopedics, has an opening for a full time PRA - Clinical Research Coordinator.  CU Sports Medicine provides comprehensive care for sports related injuries to competitive and recreational athletes of all types and ages. Research activities will focus primarily on shoulder, knee and hip outcomes.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 subjects’ research. This includes monitoring FDA, IDE, and NDA trials and maintaining compliance with clinicaltrials.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 all so assist in the development and maintenance of a record keeping system of protocol for COMIRB and other regulatory agency activities.

Examples of Work Performed
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 IRB for protocols
  • Independently generates complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado, including:
    • The Colorado Multiple Institutional Review Board (COMIRB)
    • Western Institutional Review Board (WIRB)
    • External IRB
    • Scientific Advisory & Review Committee (SARC)
    • Protocol Review and Monitoring System (PRMS)
    • Human Subjects Research Portal (HSR)
    • Clinical and Translational Research Centers (CTRC) and Clinical Trials Office (CTO)
    • Office of Grants & Contracts (OGC)
    • UCH Research Support Services (RSS)
    • UCH Research Administration
    • Denver Health Sponsored Research Office (SPARO)
    • National Institutes of Health (NIH)
    • Children’s Research Institute (RI)
    • US Food and Drug Administration (FDA)
    • Various industry sponsors or other institutional entities as required by the research projects
  • Develops (or provides oversight of the development of) clear and accurate subject informed consent documents and HIPAA authorization documents for investigators
  • Routes DUAs, MTAs, BAAs, and other clinical agreements for full execution and monitors progress following up as needed
  • Serves as OnCore trainer and “super user” for sports medicine
  • Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to Department research leadership
  • Maintains regulatory document e-files for each clinical research protocol
  • Conducts quality assurance reviews of research participant and study files and advises on best practices relating to clinical research
  • Serves as regulatory liaison between sports medicine research and University committees involves in the review and approval of research projects
  • 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
  • Hel design, organize, and conduct research using establish scientific protocols and procedures focused on implementing technology within real-world settings based on the supervision of the Principal Investigator
  • Oversee communication, timeline, and management related to deployment of specific projects and/or research studies
  • Ensure the operations of data collection to be thorough and sufficient
  • Work with the Principal Investigator to analyze data and come to scientific conclusions
  • Contribute to evaluation plans for new and ongoing projects
  • Provide additional support to the Principal Investigators as needed
Salary and Benefits:
The salary range (or hiring range) for this position has been established at $40,000 to $60,000.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.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.

Qualifications - External
Minimum Qualifications  
  • Bachelor’s degree
  • Minimum one year experience with clinical trials management
Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications
  • Excellent knowledge regarding IRB policies and procedures
  • Excellent knowledge regarding Sponsor and FDA regulatory requirements
  • Master’s degree in health related field
  • Experience with SPSS, SAS, Stata, REDCap, Excel, and Endnote
  • Experience with Microsoft Teams, Outlook, and Zoom
  • Experience with peer-reviewed manuscript preparation
  • Experience working in healthcare
  • Phlebotomy certification
Knowledge, Skills, and Abilities
To be successful in this position, candidates will need the following:
  • Great 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
  • Demonstrated success in collaborating with diverse teams
  • Ability to work effectively
  • Ability to lead, coordinate and implement research projects
  • Proven ability to work in a team environment, develop effective interpersonal relationships, and provider superior customer service
  • Ability to work independently and in a virtual environment
  • Excellent computer skills
Please go to:
cu.taleo.net/careersection/2/moresearch.ftl?lang=en to be taken to the website and type in "20156" under job number to apply.
 

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