Professional Research Assistant
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
- * 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
- * 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
- * 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)
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