TI Clinical Research Assistant 2

Department Overview

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable.

 

The Division of Pediatric Hematology/Oncology (PHO) is a medium sized program, treating about 150 newly diagnosed cancer patients a year, and with several hundred patients on active treatment and in follow-up. Many of these patients are participating on clinical trials. Thus, clinical research is integral to our clinical program. All work by the CRA ensures the scientific integrity of the data collected, and the protection of the rights, safety, and wellbeing of human research subjects. The Division of PHO sits within the Department of Pediatric of Oregon Health & Science University (OHSU) and is closely aligned with the OHSU Knight Cancer Institute. Our program is an active member of the Children’s Oncology Group (COG), a cooperative group overseen by the NCI with about 206-member institutions worldwide. The Division is also member of several smaller consortia, including TACL (Treatment Advances in Childhood Leukemia and Lymphoma) and PNOC (Pediatric Pacific Neuro-Oncology Consortium), and also participates in industrial-sponsored and investigator-initiated clinical trials.

 

Every Knight Cancer employee is expected to embody our guiding principles: 

• We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently
• We SUPPORT each other—Respect 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

Function/Duties of Position

The TI Senior Clinical Research Assistant may be involved in all facets of clinical research, from initial clinical trial development through trial closure and project completion. Clinical research conducted within the Division of Pediatric Hematology/Oncology (PHO) includes cooperative groups (National Cancer Institute [NCI] or consortia sponsored), pharmaceutical (industrial sponsored), and local investigator-initiated clinical trials. This position requires independent performance of assignments of significant complexity. This position works with people at all levels of the organization and interacts with numerous internal OHSU departments and external customers (sponsors, monitors, referring physician offices). Duties and schedule may vary at any given time on an as-needed basis.

 

Under minimal supervision, coordinates complex therapeutic interventional clinical research protocols and data management. Contributes to feasibility assessment and research protocol management. Ensures research protocol implementation. Collaborates with various OHSU departments to complete protocol-required tests and procedures, which may include the research pharmacy, Epic informatics team, clinical research billing office, and other areas.  Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.   Coordinates projects with active management of expectations, timelines, and deliverables through facilitation and coordination of steps, which may include multiple clinical research protocols.  Tracks and reports milestones.  May assist leadership across multiple protocols to ensure appropriate and consistent project management, complex logistics, quality assurance, and participant safety.  May lead data and regulatory audits of study conduct and data, emphasizing data security in concordance with federal, state, and local regulations.  May participate in onboarding and training new staff.

 

Exercises judgment within defined Good Clinical Practice and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures (Institutional Review Board) in recognizing adverse events, protocol deviations, and other unanticipated study problems and reports to senior staff appropriately.

 

Maintenance and submission of patient data and preparation for quality assurance audits and monitoring. Assist in preparation for inspections from Federal regulatory agencies. Data management on studies. May include eIRB and eCRIS/OnCore submissions.

 

Key Responsibilities:

• Gain familiarity with multiple therapeutic intervention clinical trials
• Determine potential study participants’ eligibility, facilitate informed consent process, enroll participants onto study through electronic databases
• Prompt study sample submissions