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)

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