Professional Research Assistant

Aurora, Arapahoe County
May 14, 2014

Posting Description: The major function of this position is to assist faculty in submission, administration and maintenance of clinical studies. This position will be responsible for ensuring regulatory and Institutional Review Board compliance. Study Development

    * Conduct literature search and reviews * Develop and write research protocols * Write informed consents
Institutional Review Board (IRB) related responsibilities include (but are not limited to):
    * Primary contact for all communication (includes initial protocol submissions, protocol amendments, continuing review, etc.) * Oversee COMIRB education certification in department * Submitting IRB protocols and informed consents to Colorado Multiple Institutional Review Board (COMIRB) * Submitting protocols to other regulatory bodies if applicable (i.e. Children's Hospital Colorado Research Institute) * Following COMIRB approval, acquire patient lists by working with clinical informatics and hospital billing
    * Demonstrate applicability of regulations affecting clinical trials (i.e., 21 CFR Parts 11, 50 , 56, 312 & 812, 21 CFR Part 46, ICH GCP E6 Guidelines, etc.) * Maintain compliance documentation based on research regulations, COMIRB requirements, and departmental Standard Operating Procedures (SOPs). This includes but is not limited to maintenance of IRB documentation, study training, correspondence, source data, and case report forms * Assist with the development, training and documentation of departmental SOPs
Data Collection
    * Perform study-related duties per the research protocol. This may include, but is not limited to the following: - Obtain Informed Consent - Interact with patients to gather study data - Extract data from patient charts (EPIC) - Perform other duties as delegated by the PI * Create/maintain research databases in REDCap and excel * Track subject participation within study
Data Analysis and Manuscript Preparation
    * Tabulate research data * Perform basic statistical analysis on study data and/or collaborate with statisticians * Help PIs, fellows, and residents prepare abstracts, conference presentations, and manuscripts * Submit manuscripts to medical journals * Help revise manuscript to address journal reviewers' comments and critiques if applicable.
    * Clinical study development and continuing review * Regulatory and Institutional Review Board Compliance * Data collection * Data analysis and manuscript preparation. * Collaborate with PI(s) on all research related activities (i.e. retrieve articles) - Primary work location is on the Anschutz Medical Campus, 10 physicians - Secondary work location is the Colorado Springs (COS) Memorial Hospital, 3 physicians (visiting COS location 1-4 times per month)
Applications are accepted electronically at, refer to job posting RF01389. Review of applications will continue until the position is filled. 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 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.

Minimum Qualifications: - Bachelor of Arts or Bachelor of Science in a science field (preferably in biological sciences) - Experience in Basic Science or Clinical Research

Required Competencies/Knowledge, Skills, and Abilities:

Desired Qualifications: - Clinical research or clinical data experience preferred.

Campus: Anschutz Medical Campus