Job Description: Oregon Health & Science University
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.
Job ID: 2024-29573 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Waterfront)
Overview
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
Responsibilities
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
Qualifications
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).
