University of Colorado Professional Research Assistant in Aurora, Colorado
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.
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)
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.
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.
Minimum one year experience with clinical trials management
Applicants must meet minimum qualifications at the time of hire.
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
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
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Feb 8, 2021
Unposting Date Ongoing
Posting Contact Name Lindsey Renn
Posting Contact Email email@example.com
Posting Number 00781474
Req ID: 20156
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.