This position is responsible overseeing all regulatory components of clinical research studies in support of the mission of the Knight Cancer Institute. The position has ownership of the 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. In addition, the position also has oversight over the feasibility assessment, essential regulatory document completion, beacon build, eCRIS, and budget and contract negotiation processes. The position also has ownership of all regulatory tasks that must be completed over the lifetime of the clinical research studies they support, 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. Strong organizational, interpersonal and writing skills are required. Ability to clearly organize and/or adapt to multiple priorities and 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.
Bachelors Degree and at least 4 years of related experience
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 MS Office (e.g. MS Excel, Access, Word and PowerPoint)
Must have demonstrated excellent customer service skills both on the phone and in person
Must possess energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Two years clinical trials/research experience
Project management experience
Experience using project management software (eg, MS Project)
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 r...esearch. 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