Research Regulatory Assocate (Senior 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: management of research educational activities covering a wide range of topics related to clinical research in consultation with the Regulatory Knowledge & Support (RKS) Manager and OCTRI Leadership. The individual will develop classes and training materials with input from institutional content experts and develop and lead educational activities for the research community consistent with OHSU research/healthcare policies, NIH/FDA regulations, and Good Clinical Practices. The OCTRI workforce development program provides training to hundreds of OHSU research coordinators and faculty each year. This individual will also provide direct 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. This position requires knowledge and experience applying federal, state, and institutional regulations and policies to clinical trials. OCTRIs RKS team consults on and provides services to hundreds of research protocols each year.

The Research Regulatory Associate 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. Demonstrated 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.

• Doctorate degree in relevant field; OR Masters degree in relevant field and 5 years of relevant work experience; OR Bachelors degree with major courses in field of research and 9 years of relevant experience
• Research experience including IRB submissions and clinical research study conduct
• Demonstrated knowledge of 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)

• Doctorate or Masters degree in clinical research related fiel
• 9+ years of clinical research experience including IRB submissions and clinical research study conduct. Experience training/onboarding research staff is preferred
• 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 both a cover letter and a resume or CV.

Working conditions: 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.

Physical demands & 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. Able to perform the essential functionsof the position with or without accommodation

Software Powered by iCIMS
www.icims.com