Department Overview:
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.
Therapeutic Interventional (TI) trials are treatment studies that involve people who have a disease or underlying condition. They include the administration and testing new treatments or new ways of using existing treatments, such as new drugs, vaccines, Cell Therapies, Devices, or experimental approaches to surgery or radiation therapy.

• Working with the regulatory management team to complete all regulatory documentation in accordance with their role as required by the OHSU IRB and sponsor
• Creation of study trackers and organization tools
• Assisting in the verification of patient eligibility
• Development of data collection instruments and assistance with regulatory
• Data entry
• Assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines
• Maintenance of study patient records and source documentation
• Coordinating orders, scheduling and study drug administration with the clinical team
• Supporting clinical care team with completion of research required tests and assessments
• Act as liaison between research protocol and clinic staff, pharmacy, and research participants
• Ensuring that patient billing is accurate and assisting manager and financial team in verifying appropriate clinical trial billing. Participation in patient consenting
• Support and periodic coverage to and across study teams, as delegated by the Clinical Research Manager. This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed