This position is responsible for overseeing regulatory components of clinical research studies in support of the mission of the Knight Cancer Institute. The position also has ownership of regulatory tasks that must be completed over the lifetime of the clinical research studies they support, including the processing of protocol amendments, investigator brochures, consent form updates, and applications for continuing approvals.
The successful candidate will have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research. They will facilitatethe conduct of clinical research studies with good understanding and communication of study protocol requirements under general supervision.
The key responsibilities for this role will include but are not limited to:
Active management of the study modification process
Direct responsibility for preparation of all documentation required by the Knight CRRC and OHSU IRB
Oversight of modifications to the business processes/documents
Active management of other regulatory obligations around questionnaires, compliance, and reporting
Assistance to the Regulatory Project Manager and Study Team
Management of changes in process and policy by providing guidance on meeting regulatory requirements
Bachelor's degree and at least one year of clinical trials or research experience
Working knowledge of FDA, DHHS and other agency guidelines that govern clinical research
Strong organizational, interpersonal and writing skills
Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time
Attention to detail, strong understanding of the scientific method, project management, customer service, and critical judgment skills
Innovation and problem solving
Above average time management skills
Bachelor's degree with coursework in science
1 year regulatory experience
Project management experience and/or training
Experience using project management software (eg, MS Project)
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.
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm