Clinical Research Associate I, Medicine
Position Summary
The Department of Medicine, Division of Behavioral Medicine is seeking a Clinical Research Associate I. In this role the Clinical Research Associate I will manage and coordinate a large-scale research study on temporomandibular disorders and chronic overlapping pain conditions.
The candidate will perform head, neck, and body examinations to obtain clinical data and to collect oral and biological samples as outlined in IRB-approved protocols. Additionally, the candidate must have experience with conducting research and working with RedCap databases and excel.
The candidate must be experienced with obtaining participant consent, developing standard operating protocols for research, and IRB submissions. Must also have completed CITI (Collaborative Institution Training Initiative) training certification in the ethics of research with human subjects. The candidate must be willing to travel for training.
Recruitment and Participant Management
- Screen and recruit eligible study participants using IRB-approved study participant recruitment methods
- Schedule participant visits and maintain study timeline
- Obtain informed consent according to IRB and regulatory requirements
- Independently prioritize daily activities to ensure compliance with research requirements of all assigned study participants.
- Discuss study issues with the study investigators, serving as a liaison/advocate between the participant/family and the investigators.
Data Collection
- Provide education and information to study participants and families about clinical research participation and compliance.
- Conduct standardized examination of head, neck, and body. Review collected data
- Collect and manage biological samples (e.g., blood, saliva, stool)
- Track study supplies and research record and maintain accurate source documentation and case report forms
- Identify study implementation problems including unusual occurrences, safety concerns, issues with compliance with study requirements. Take an active role in resolving any implementation problems by participating in the development of study deviation reports and corrective action plans.
Administrative and Meetings
- Coordinate clinical research studies from startup through closeout
- Communicate with principal investigators, sponsors, monitors, and study participants and provide reports to the Principal Investigators in a timely manner.
- Prepare for monitoring visits, audits, and inspections
- Provide input into the development of amendments regarding study implementation.
IRB and compliance
- Ensure compliance with FDA, GCP, HIPAA, and institutional policies
- Devise, plan, and implement strategies and systems necessary to ensure adherence to and compliance with the assigned clinical research studies.
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