Clinical Research Monitor
OHSU Knight Cancer Institute
Clinical Research Quality & Administration
The CRQA Clinical Research Monitor is considered a centralized resource and works in support of OHSU sponsor-investigators that are conducting cancer-related research under an IND or IDE. Evaluates the conduct of these clinical trials on behalf of the sponsor-investigator to ensure research integrity and compliance with the protocol, institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice (GCP). Participates in formal and informal training relative to the position responsibilities described herein. Will identify and actively propose revisions to educational materials, toolkits and SOPs to ensure consistency in messaging related to regulatory compliance and research integrity.
Independently organizes monitoring activities according to approved monitoring plan(s). Collaborates with the sponsor-investigator and research team to ensure transparency in the monitoring process and conducts a respectful and efficient review from initiation to confirming final resolutions have been implemented.
• Throughout the life of the trial, ensures compliance with the IRB approved protocol as well as compliance with all regulatory requirements, institutional policies, and NCI policies relating to human subject research
• Identifies additional issues relating to compliance and, with the assistance of Knight Leadership, collaborates with research staff and the appropriate OHSU department [e.g. IRB, etc.] to develop a plan for resolution
• Develops and maintains a detailed tracking mechanism [e.g. spreadsheet or database] to document all aspects of monitoring data; i.e. monitoring dates, activities, findings, action items, due dates, etc.
• Conducts monitoring activities at external locations which may include travel within the continental United States. Extent of travel may be as much as 50%. Use of an institution-issued procurement card and management of expenses within travel policies is expected
Master’s degree with major courses in relevant field and 3 years of relevant experience;
OR Bachelor’s degree with major courses in field of research (or RN or allied health professional) and 5 years of relevant experience;
OR Bachelor’s degree and 7 years of relevant experience.
• Demonstrated experience with Required Qualifications
• ACRP or SoCRA Certifications [e.g. CCRC, CCRA, CCRP, etc.]
For more information or to apply online, visit the job on the OHSU Careers site HERE