Research Regulatory Associate (Research Associate)

The Oregon Clinical Translational Research Institute (OCTRI) at OHSU is a catalyst for scientific collaboration, translation of biomedical advances into the community, innovationand research growth in Oregon and beyond. OCTRIs mission is to enhance the efficiency and quality of rigorously translating research ideas into impact. To accomplish our mission, our 80-90 employees spread across 13 teams provide a broad expanse of clinical and translational services that include training, funding, research support, and community engagement. OCTRI is part of the National Center for Translational Sciences (NCATS)-funded CTSA consortium that encompasses 50+ hubs around the country. Visit our website to learn more: octri.org.

The duties of this position include: independent coordination of research educational activities covering a wide range of topics related to clinical research as directed by the Regulatory Knowledge & Support Manager and OCTRI Leadership. The individual will develop training materials with input from content experts and coordinate educational activities for the research community consistent with OHSU research/healthcare policies, NIH/FDA regulations, and Good Clinical Practices. The Individual will also provide regulatory consultation and services to OHSU investigators for their clinical research projects including Institutional Review Board (IRB) submissions, Data and Safety Monitoring Board (DSMB) Management, developing data and safety monitoring plans, protocol development and other regulatory submissions.

Individual must be detail oriented and able to track multiple projects simultaneously. Must be able to problem solve, take initiative and have strong interpersonal, oral and written communication skills. Ability to work independently and efficiently under pressure to meet multiple deadlines and take the lead and see project through to completion is critical for this position.

• Masters degree with major courses in relevant field and 3 years of relevant experience; OR Bachelors degree with major courses in field of research (or RN or allied health professional) and 5 years of relevant experience
• 3 years of research experience including IRB submissions and clinical research study conduct
• Demonstrated knowledge of basic research design and clinical research regulations
• Proficient in computer applications including Windows, Word, Excel and PowerPoint
• Excellent verbal and written communication and customer service skills
• Excellent interpersonal skills to interact with faculty and investigators, staff, students, and visitors at all levels within OHSU and in the community
• Superb organizational skills and fine attention to detail
• Ability to work in a fast-paced atmosphere with many competing demands and priorities
• Ability to work independently and remotely (during OHSU Modified Operations)
• Work location is an office setting at the OHSU Marquam Hill campus with remote online work during OHSU Covid-19 Modified Operations
• No exposure to noise, human tissues or radiation
• Occasional extended hours to support special projects
• Must be able to sit and work on a computer for the majority of the eight hour work day, ride the tram, and lift 20 lbs
• Able to perform the essential functionsof the position with or without accommodation

• Masters degree in clinical research related field
• 5+ years of clinical research experience including IRB submissions and clinical research study conduct
• Experience with FDA submissions, GCP, and research project management
• Experience and demonstrated compliance with OHSU research policies
• Training/education experience including developing educational materials
• ACRP, SOCRA, CIP, or RAPS certification strongly preferred

Apply online here. To be fully considered for this position, please be sure to upload botha cover letter and a resume or CV.

Working conditions: Work location is office setting at the OHSU Marquam Hill campus with remote online work during OHSU Covid-19 Modified Operations. No exposure to noise, human tissues or radiation. Occasional extended hours to support special projects.

Physical demands and equipment usage: Must be able to sit and work on a computer for the majority of the eight hour work day, ride the tram, and lift 20 lbs.

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