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 University of Colorado Denver Department of Orthopedics, Foot & Ankle and Adult Reconstruction Sections have an opening for a full time Professional Research Assistant (PRA). The PRA will serve as the Research Coordinator/Regulatory Manager for clinical and basic science studies for both the Orthopedic Foot & Ankle service and the Adult Reconstruction (aka Joint Replacement) service.
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, writing and submitting grants, managing continuing reviews of protocols, preparing and submitting abstracts, papers and manuscripts. 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 and other clinical trials.
The PRA will oversee students working directly on projects. 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 also assist in the development and maintenance of a record keeping system of protocols for COMIRB and other regulatory agency activities.
Examples of Work Performed
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
Interact with institutional review board for protocols
Interact with sponsors regarding clinical studies
Interact with patients during study visits
Maintain databases of clinical studies
Assist with preparation of manuscripts and research presentations
Assist with preparation of grants and project reports
Perform Basic statistical analysis
Liaise with department research director on collaborative projects
Oversee research students and their projects
Participate in weekly Foot and Ankle Conference
Provide additional support to the Principal Investigators as needed
Good command of the English language, both written and verbal
Excellent computer skills
Firm understanding of the principles and practices of clinical research
Ability to write and edit grants and manuscripts on orthopedic topics
Knowledge, Skills, and Abilities
- Ability to work with a great attention to detail
- Ability to work with colleagues and patients in a confidential and professional manner
- Excellent organizational and communication skills both written and verbal
- Ability to problem solve and multi-task.
Knowledge of patient reported outcomes
Excellent knowledge regarding IRB policies and procedures
Excellent knowledge regarding Sponsor and FDA regulatory requirements
Minimum one years’ experience with clinical research
Master’s degree in health related field
Experience with SPSS, SAS, Microsoft excel, Stata and REDCap
Knowledge of, and experience with, NIH PROMIS
Salary and Benefits
Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.
The University of Colorado Denver 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.
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.
Total Compensation Calculator:
Diversity and Equity
Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
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.
Special Instructions to Applicants:
Review of applications will begin October 9, 2018, and will continue until the position is filled. Questions should be directed to Susan.Price-Allely@ucdenver.edu
Application Materials Required:
Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 14898
When applying, applicants must include:
A letter of application which specifically addresses the job requirements and outlines qualifications
A current Resume/CV
The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.
Please do not submit any of your application material (via email) to the job posting contact.