Clinical Research Assistant
Job Overview
The Clinical Research Assistant provides administrative support for clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. This role supports the achievement of research program and/or study objectives.
Shift Details
SHIFT CCBD Clinical Research
Monday - Friday
Rotating shifts: 8am-4:30pm, 8:30pm-5pm, 9am-5:30pm, 9:30am-6:00pm (Fridays only)
Some weekend shifts may be required, depending on business needs.
Essential Functions
- Assists regulatory team with Institutional Review Board (IRB) preparation and submission
- Screens and schedules participants in clinical research programs and/or studies
- Consents subjects and/or families for registry or non-interventional research studies
- Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities
- Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols
- Collections, prepares, processes, ships and maintains inventory of research specimens
- Maintains subject level documentation and prepares documents, equipment and/or supplies
- Provides input for and assists with developing IRB related documents
- Collaborates with coordinating staff to maintain appropriate documentation
- Identifies issues related to operational efficiency and shares results with supervising coordinator staff and/or management
- Maintains compliance with institutional requirements and policies
- Maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research
- Participates in sponsor-required training
- Participates in team meetings
- Proactively includes others in decision making and escalates issues to management as necessary
- Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data
- Recognizes and reports vulnerabilities related to security of physical and electronic data
- Adheres to and participates in the development and assessment of quality assurance
- Assists with recognizing trends related to data quality and escalates as appropriate
- Utilizes electronic data capture systems, technologies and software necessary for clinical research program and/or study operations
- Scores tests, enters data and completes required forms accurately and according to protocol
- Aids in the development of data collection documents and instruments
- Identifies issues related to data capture, collection or management and escalates to supervising coordinator staff and/or management
- Affirms participant care expenses have appropriate financial routing and subjects are paid as relevant for participation in clinical trials
Qualifications
- Education: High school diploma or equivalent is required
- Experience: None
- Licensure(s): None
- Preferred Qualifications: Previous specimen processing/handling experience, Previous laboratory experience
Benefits
Here, you matter. As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career. As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April. Children’s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.
EEO Statement
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.