TI Clinical Research Associate

Department Overview

The Department of Neurological Surgery in the OHSU School of Medicine is a safe, respectful, and welcoming place for people of all races, cultures, ethnicities, genders, national origins, abilities, ages, colors, religions, and sexual orientations. We are committed to learning, promoting inclusion, and working to abolish inequities in our workplace here at OHSU, in our region, in our nation, and in our world. The Department of Neurological Surgery promotes an equitable work environment with a strong commitment to diversity. All department members will actively participate in training and events that reinforce and expand on this commitment.

Function/Duties of Position

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. 

Study Coordination- Responsible for coordinating many aspects of oncology clinical trials from startup to closeout and assuring conduct of trials in accordance with NCI and FDA guidelines. This includes but is not limited to:

• Be able to navigate complex oncology clinical trial protocols that can be upwards of a 670 page document
• Schedule any necessary site-initiation/training visits for clinical trial start-up.
• Explain trial logistics to oncology patients, triage and ensure all patient questions are answered.
• Assist the PI or Sub-I with the informed consent process
• Assist the PI or Sub-I with the collection and documentation of subject adverse events
• Document study required source documentation in the subjects eMR or paper source
• Communicate with the PI or Sub-I during patient visits regarding dose modification parameters
• Serve as the liaison between the study staff and the medical monitor for patient level protocol questions
• Serve as the point of contact for the clinical staff to provide protocol guidance for patient management on trial
• Serve as the liaison between subjects, physicians, and sponsors.
• Assist CRA specialist or take lead in resolving clinic operations issues
• Field research patient calls to the personnel most appropriately trained to address their questions/needs
• Coordinate recruitment, scheduling, preparation and testing of research subjects
• Place research lab and procedure orders
• Review patient records to screen for potential trials
• Problem solve barriers for patients to participate in clinical trials. This may include working with their PCP or local oncologist to get procedures done close to home, connecting them to social work to find travel and financial resources, setting up virtual medicine visits or referring to another useful resource.
• Performing drug accountability with patients and documenting in the patients eMR or on paper source.
• Prepping for upcoming visits including reviewing patient records to look for newly reported AEs, Conmeds and other pertinent information to be reviewed with the patient and provider at the visit
• Submit insurance pre-authorization request for new patients on study
• Schedule research biopsies, scans, ECHOs/ECGs, Ophthalmology appointments, dermatology visits and other research required procedures as needed.
• Provide clinic training in-services as needed
• Ship out central study labs as needed
• Prepare and ship subject samples as needed by study.
• Review patient data to determine appropriate eligibility and deficiencies regarding enrollment into clinical trials. Confirm with investigator that subject meets appropriate inclusion criteria for clinical trial.
• Communicate all pre-treatment requirements to investigator/clinical staff.
• Obtain and submit imaging studies, pathology, or other samples as required by protocol.
• Review billing schedule and billing errors. Ensure appropriate patient billing and reimbursement.
• Submit Invoices for tasks related to their role
• Review and report adverse events or Unanticipated Problems to IRB/study sponsor.
• Obtain vital sign measurements for study patients; documenting contacts with study subjects and vital signs as appropriate.
• Procure and process human biological specimens (including but not limited to blood, urine, feces, sputum, tissue) in adherence with protocol parameters and appropriate training.
• Communicate and facilitate oncology trial guidelines, timelines, and patient specifics with Research Pharmacy, Clinics and various service departments to coord