This position is responsible for overseeing all regulatory components of research studies in Diagnostic Radiology. The position works independently on various aspects of the study start-up process, including feasibility questionnaires, tracking of clinical trials start-up metrics, regulatory binder set-up, consent form and protocol development, local and central IRB submissions and all communications/responses, CTRP registration workflows, and flowsheet updates. The position also has ownership of all regulatory tasks that are completed over the lifetime of a clinical research study, including the processing of protocol amendments, investigator brochures and safety reports, 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. The Regulatory Project Manager will support investigator-initiated and industry-sponsored clinical research studies across Diagnostic Radiology. Major department projects include: first-in-human testing of a novel device for prostate cancer diagnosis; novel MR imaging techniques to evaluate drug delivery in pancreatic cancer; use of novel imaging agents in conjunction with PET/MRI to differentiate pseudoprogression from tumor progression in glioblastoma; and drug trials (phases 1-3) involving the use of novel radionuclides for precision targeting of cancer cells.
Bachelors Degree and 1 to 3 years of clinical trials, research, or other relevant experience
Ability to learn web-based databases quickly
Excellent analytical, organizational, and communication skills (both written and verbal)
Ability to work independently and as part of a team while being collaborative in resolving problems
Ability to prioritize work demands and manage time appropriately; ability to meet deadlines while juggling multiple projects
Demonstrated excellent customer services skills on the phone, via email, and in person
Ability to use tact and diplomacy to maintain effective working relationships
Proficiency with computers and Microsoft applications (Excel, Outlook, Access, Word, PowerPoint)
Demonstrated record of reliable attendance, punctuality, and proven successful performance
At least one year of regulatory experience
Knowledge of medical terminology
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 [email protected]
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