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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 OHSU Knight Cancer Institute TI Sr. Clinical Research Assistant (TI Sr. CRA) is responsible for the collection, entry, general management of oncology study data and all regulatory components for oncology clinical trials. Under minimal supervision, coordinates complex therapeutic interventional clinical research protocols and data management.

This position has ownership of the oncology study start-up process, including the tracking of oncology 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 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.

Data management duties include ensuring accurate and complete research data is collected from oncology clinical trial study subjects and entered into the appropriate Case Report Forms. This role will also assist with the coordination of oncology clinical trial monitoring visits, data query resolution, and quality control of collected research data.

This position must maintain a working knowledge of oncology data, a vast variety of differing electronic database systems, a working collaboration with our internal and external partnerships, of FDA, DHHS and other agency guidelines that govern clinical research.

* Therapeutic Interventional 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, experimental approaches to surgery or radiation therapy, etc.

OHSU Research classification: TI Sr. Clinical Research Assistant, represented by the Research Workers United (RWU), subject to the active collective bargaining agreement between OHSU and RWU.

Education and experience:

Bachelor's Degree in relevant field AND 1 year of relevant experience OR

Associate's AND 3 years of relevant experience OR

4 years of relevant experience OR

Equivalent combination of training and experience.

Knowledge, skills, and ablitilites:

• Commitment to overall data integrity with ability to communicate and advocate for data quality
• High degree of attention to detail
• Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time
• Ability to follow through and complete tasks
• Ability to track progress and update others on status of data collection
• Strong innovation and problem solving
• 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
• Proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint
• Ability to generate a variety of reports in MS Word and Excel
• Ability to use tact and diplomacy to maintain effective working relationships
• Adaptability
• Strong critical thinking skills

• Strong understanding of the scientific method
• Demonstrated project management skills or project management experience
• Demonstrated customer service skills or customer service experience

All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti‑racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu