Oregon Health & Science University Research Regulatory Assocate (Senior Research Associate) in Portland, Oregon
The Oregon Clinical Translational Research Institute (OCTRI) at OHSU is a catalyst for scientific collaboration, translation of biomedical advances into the community, innovation and research growth in Oregon and beyond. OCTRI’s 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. OCTRI’s 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 Master’s degree in relevant field and 5 years of relevant work experience; OR Bachelor’s 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 Master’s 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 functions of the position with or without accommodation
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 firstname.lastname@example.org.
Recruitment ID: 2021-7720
External Company URL: dturner
Posting Department: Oregon Clinical and Translational Research Institute (OCTRI)
Posting Pay: $53,300.52-$79,834.30
Posting FTE: 1.00
Posting Schedule: Monday - Friday, occasional weeknights or weekends may be needed. Position is currently full-time teleworking
Posting Hours: 8a-5p