Function/Duties of Position

The Senior Clinical Research Associate is the Lead Quality Assurance Monitor/Protocol Specialist for the Western States Node (WSN), a member of the National Drug Abuse Treatment Clinical Trials Network (CTN).

• Ensures all data collected is reviewed for quality assurance and is compliant with study and non-study regulations, including, but not limited to the study protocol, HIPAA, GCP, ICH guidelines and internal Standard Operating Procedures (SOPs).
• Supervises and monitors clinical trials being implemented within the Node. The WSN simultaneously conducts multiple multi-site behavioral and pharmaceological clinical trials.
• Provides initial and ongoing training for other QA Monitors/Protocol Specialists within the Node.
• Assists in site preparation for study implementation and assist in infractructure activities as needed. 
• Attending local and national conference calls.
• Assists in developing local Standard Operating Procedures.
• Schedules and conducts quality assurance visits.
• Prepares reports and disseminates per CTN guidelines; confirms that the trials are being implemented in compliance with State, Federal and International Standards.
• Train research staff in Good Clinical Practice, Informed Consent, Timeline Follow Back and other data collection forms as needed; reviews Adverse Events, Serious Adverse Events and Protocol Deviations; and monitors trial progress. 

Required Qualifications

• Master’s degree in relevant field AND 5 years of clinical research coordination experience; OR
• Bachelor’s degree in relevant field AND 9 years of clinical research coordination experience; OR
• Equivalent combination of training and experience.

• Knowledge of the field of health research; able to work independently.

• Intermediate skills in Microsoft applications.

Preferred Qualifications

• Coursework in research methodology, project management.

• Experience with project management, quality assurance monitoring, experience with institutional review boards.

• Experience in clinical trials, GCP, human subjects research, ICH and SOCRA.

Additional Details

• Must be able to travel for site visits. Volume of travel may vary depending on project needs. Travel to national meetings as necessary.

• Remote position.

All are welcome

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.