Experience as part of a team with all 8 competency domains is expected. *
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
Clinical Research Coordinator - Associate
- Participant Screening and Recruitment
- Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent.
- Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
- Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
- Demonstrates the ability to document data in accordance with ALCOA-C principles.
- Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
- Demonstrates accurate implementation of protocol procedures.
- Explains and performs study related management activities.
- Performs study procedures with minimal supervision.
- Triages subject issues appropriately.
- Schedules and runs study visits with complex data collection.
- Perform Quantitative Sensory Testing (QST) inside and outside of MRI, and willingness to be trained
- Preparation datasheets, questionnaires, study related documents
- Tracking and communication with study subjects
- Complete subject documentation and follow up
- Assist with data entry and capture
- Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
- Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
- Submit Human Subjects Incentive Program (HSIP) requests
- Assist with eResearch submissions
- Travel to the North Campus MRI for study visits or Research Pharmacy
Clinical Research Coordinator - Technician
This position provides study coordination for simple and moderately complex clinical research studies. As a member of the research team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.
- Performs moderately complex study procedures with accuracy.
- Tracking and communication with study subjects
- Triages subject concerns appropriately.
- Assesses studies for execution and troubleshoots potential implementation issues.
- Completes simple to moderately complex data collection during study visits.
- Assists with local quality control efforts.
- Submit Human Subjects Incentive Program (HSIP) requests
- Assist with data entry and capture
- Travel to the North Campus MRI for study visits or Research Pharmacy
Clinical Research Coordinator - Assistant
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. Demonstrates the ability to screen participants for study eligibility.
- Performs study procedures with accuracy.
- Tracking and communication with study subjects
- Understands protocol structure and how to interpret study requirements to ensure study compliance.
- Understands proper documentation techniques, as outlined in the ICH-GCP guidelines.
- May assist research coordinator in conduct of SIV; attends SIV.
- May assist in and attend monitor visits and/or audits.
- Submit Human Subjects Incentive Program (HSIP) requests
- Assist with data entry and capture
- Travel to the North Campus MRI for study visits or Research Pharmacy
Supervison recevied: This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.
Supervison excerised: None