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 require management of complex clinical research studies involving a very vulnerable and sick population.
This position is responsible for overseeing regulatory components of clinical research studies in support of the mission of the Knight Cancer Institute. The position also has ownership of regulatory tasks that must be completed over the lifetime of the clinical research studies they support, including the processing of protocol amendments, investigator brochures, consent form updates, and applications for continuing approvals.
Facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements.
Key responsiblities include:
Active management of the study modification process.
Evaluate study modifications and other changes to the conduct of the study to identify feasibility and all downstream impacts to systems in place to support study conduct and collaborate with responsible parties to ensure appropriate changes made to those systems (eg, Beacon builds, Research Pharmacy deliverables, eCRIS study build, regulatory document collection, budget negotiations, and training). Communicate applicable changes to responsible parties.
Direct responsibility for preparation of all documentation required by the Knight CRRC and OHSU IRB , as appropriate for the study modification, in collaboration with the principal investigator, and active management of the project throughout the review process.
This role is responsible for managing all communications with the review boards, sponsor and other involved parties (eg, IND/IDE Associate), along with study tool (flowsheets, VIA Oncology, Bridge Regulatory Dashboard) updates. Maintain records on each study to ensure regulatory compliance with institutional policies and ICH/GCP guidelines.
Oversight of modifications to the business processes/documents , as required based on the specific study modification by coordinating all parties with direct responsibilities for the deliverables including but not limited to: Beacon builds, Research Pharmacy deliverables, eCRIS study build, regulatory document collection, and budget and contract negotiations. Document study team training on modification changes to study documents (protocol, consent form, IB, etc).
Actively manage all other regulatory obligations including preparing continuing review questionnaires (CRQs), unanticipated problem (UP) reports, protocol deviation (PD) reports, and reportable new information (RNI) reports in accordance with institutional policies, sponsor requirements and other regulatory requirements.
Assist Regulatory Project Manager and Data Manager with the following:
Attend study initiation meetings, coordinate monitoring visits, communicate specific study requirements to the research team and build regulatory binders. Participate in the development of OHSU physician initiated protocols. Assist in monitoring and coordination of OHSU multi-center studies according to protocol.
Recommend, implement and monitor changes in process and policy issues, and provide guidance on meeting regulatory requirements.
Bachelor's degree and at least four years of related experience
Strong organizational, interpersonal and writing skills
Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time
Attention to detail
Understanding of the scientific method
Critical judgment skills
Innovation and problem solving
Above-average time management skills
Excellent customer service
Bachelor's degree with coursework in science
Project management experience
Project management training, or experience using project management software (eg, MS Project)
One year regulatory experience
Every Knight Cancer employee is expected to embody our guiding principles:
We act BOLDLYBreakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently.
We SUPPORT each otherRespect leads to trust, which leads to excellence.
We work as a CONNECTED team We must leverage our collective brain power to conquer cancer because no one individual can do it alone.
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