The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment requires management of complex therapeutic interventional (TI) trials and clinical research studies involving a very vulnerable and sick population.

• Responsible overseeing all regulatory components of oncology clinical research studies in support of the mission of the Knight Cancer Institute.
• Ownership of the oncology study start-up process, including the tracking of clinical trials start-up metrics, communicating with all start-up process owners and participants, consent form development, CRRC and IRB submissions and all communications/ responses, CTRP registration workflows, flowsheet updates, and VIA Oncology updates.
• Oversight over the feasibility assessment, essential regulatory document completion, beacon build, eCRIS, and budget and contract negotiation processes.
• Ownership of all 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 and safety reports, consent form updates, and applications for continuing approvals.
• Maintains a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research.
• Facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements

Education and experience: 

• Bachelor's in relevant field AND 1 year of relevant experience OR
• Equivalent combination of training and experience

Knowledge, skills, and abilities: 

• 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 tight deadlines at one time
• Attention to detail
• Strong understanding of the scientific method
• Strong project management skills
• Strong customer service skills
• Critical judgment skills
• Innovation and problem solving
• Above avergage time management skills
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Intermediate skills with Microsoft Office (Excel, Outlook, Access, Word, and PowerPoint) on Window OS.
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships

• Bachelor's degree with coursework in science
• Project management training
• Two years clinical trials/research experience
• One year regulatory experiene
• Project management experience
• Experience using project management software (eg, MS Project).

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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 aaeo@ohsu.edu.