The Division of Pediatric Hematology-Oncology is Oregon's premier center for childhood cancer and blood disorders. We are nationally recognized as a comprehensive center in pediatric cancer diagnosis, treatment, advanced care and research.

This position is responsible for overseeing regulatory components of oncology clinical research studies in support of the mission of the Division of Pediatric hematology Oncology. The position also has ownership of regulatory tasks that must be completed over the lifetime of the oncology 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. Strong organizational, interpersonal and writing skills are required. Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time is necessary. Attention to detail, strong understanding of the scientific method, project management, customer service, and critical judgment skills are essential. Requires general supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements; above average time management skills.

Bachelor's Degree in relevant field AND1 year of relevant experience ORAssociate's AND 3 years of relevant experience OR4 years of relevant experience OREquivalent combination of training and experience.

Job Knowledge and Skills:

• Ability to prioritize multiple tasks at one time.
• Must have excellent communication, analytical and organizational skills: both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• High level of organization, attention to detail, troubleshooting, and prioritizing skills.
• Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint). Typing 60wpm.

• Bachelor's degree with coursework in science.
• Project management training.
• Minimum of 1 year regulatory experience.
• Project management experience.
• Experience using project management software (eg, MS Project).

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