Professional Research Assistant
University of Colorado - School of Medicine
Professional Research Assistant
The Department of Orthopedics has an opening for a full time Professional Research Assistant (PRA). The PRA will serve as the Research Coordinator/Regulatory Manager for a clinical study on the efficacy of pain medications for chronic spine pain.
This position will assist the Principal Investigator with all aspects of administrative activities related to the submission of Institutional Review Board (IRB) protocols to the Colorado Multiple Institutional Review Board (COMIRB), the FDA, and other regulatory agencies. This includes 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. The PRA will interact with subjects during study visits and ensure completion of all necessary documentation, as well as facilitate study-related billing.
Duties include, but are not limited to:
- Maintain complete records of all research related documents
- Recruit, schedule, and screen potential study subjects
- Conduct study visits
- Interact with institutional review board for protocols
- Assist with preparation of manuscripts and research presentations
- Assist with preparation of project reports
- Assist with preparation of DSMB reports
- Manage the study's electronic database
- Provide additional support to the Principal Investigator as needed
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 University of Colorado strongly supports the principle of diversity. 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 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.
Knowledge, Skills, and Abilities:
- Good command of the English language, both written and verbal
- Excellent computer skills
- Firm understanding of the principles and practices of clinical research
- Excellent knowledge regarding IRB policies and procedures
- Knowledge regarding FDA IND regulatory requirements
- Ability to work with a great attention to detail, and work with colleagues and patients in a confidential and professional manner.
- Excellent communication skills, both written and verbal
- Ability to problem solve and work independently
- Bachelor's degree
- Minimum one years' experience with clinical research
- Master's degree in health related field
Special Instructions to Applicants:
Questions should be directed to Emily.Lindley@ucdenver.edu
Application Materials Required:Cover Letter, Resume/CV
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID:
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 (Optional)
Please do not submit any of your application material (via email) to the job posting contact.
Job Category: Faculty
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20259 - SOM-Orthopedics
Posting Date: Apr 18, 2017
Closing Date: Ongoing
Posting Contact Name: Emily Lindley
Posting Contact Email: email@example.com
Position Number: 00729072