University of Colorado Professional Research Asst in Aurora, Colorado
University of Colorado – School of Medicine
Professional Research Asst
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 Division of Gastroenterology seeks a professional research & regulatory assistant for clinical research projects in digestive health. The successful candidate will be part of a collaborative research program focusing on gastroesophageal reflux disease, eosinophilic esophagitis, and esophageal motility disorders. Responsibilities will include research protocol enrollment and oversight, specimen collection, and data management. The position requires an ability to work independently, attention to detail, and ability to maintain organized protocol documentation and data.
Examples of Work Performed:
Under the supervision of the Clinical Research Manager/ PI, the primary responsibility of the Professional Research Assistant is to serve as the clinical research coordinator in support of various research activities and regulatory.
Clinical Research Coordinator:
Collaborating with principal investigators & co-investigators to enroll clinical trial patients
Conducting study visits
Overall compliance with the policy and procedures for conducting good clinical trials
Screening, consenting and enrolling study participants
Collecting, processing and storing samples for research
Medication compliance tracking and coordinating protocol procedures
Collect and report all patient reported adverse drug reactions and other serious adverse events
Patient education and follow-up per protocol guidelines
Routine meetings with monitors to reconcile data management issues
Participation in investigator’s meetings
Preparing and submitting compliance documentation for the institutional review board
Submission to the Human Research Subjects Portal for UCH-RSS review and approval
Maintenance of databases
Abstracting data from patient charts and electronic medical records
Regulatory Research Activities:
- Preparation and submission of complete and accurate regulatory packages to all applicable regulatory bodies which may include, but is not limited to, the following:
o Colorado Multiple Institutional Review Board (COMIRB)
o Denver VA Research and Development Committee
o University of Colorado Hospital Research Support Services (UCH-RSS)
o Western IRB
Draft informed consent and HIPAA documents in accordance with institutional guidelines.
Participates in the consent negotiation process between institution and sponsor
Serves as regulatory contact person for ongoing clinical research trials.
Meets with representatives from sponsoring trials as needed
May be called on to conduct, or assist in, on site visits with trial sponsors.
Completes and submits continuing reviews, amendments, and safety updates as needed
Updates database with regulatory submission and approval dates
Communicates regulatory status with coordinating team on an ongoing basis and in an timely manner
Responsible for version control and tracking of study documents
Bachelor’s degree in science or equivalent education and work experience
Prefer a minimum of two years’ experience with coordinating and managing administrative and clinical research activities.
Strong organizational skills and attention to detail essential.
Demonstrated experience with creating and maintaining clinical research projects and clinical trials
Ability to multi-task
This position requires a high level of proficiency with computers and use of Microsoft Access, Excel, Outlook, Word, and other University and Departmental systems as required.
Advanced computer skills, particularly Microsoft Excel, REDCap and EPIC.
Knowledge and experience with IRB policies and procedures.
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 atEmployee 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:https://www.cu.edu/employee-services/total-compensation
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.
Organization: *H0001 -- Anschutz Medical Campus
Title: Professional Research Asst
Requisition ID: 14296