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 coordinate treatment for study patient.
• Perform or collaborate with research team member's to ensure that data entry and chart review/abstraction is completed to verify that key data has been reported to the clinical research database or reported to the sponsor in the required format.
• Review follow up data clarifications or data queries and report within study timeline.
• Maintain and update or collaborate with research team member's to ensure that subject data records are correct for study analysis and survival.
• Assist investigators with any special requests for data retrieval and/or evaluation and analysis of clinical data for ongoing research studies.
• Ensure compliance with FDA and regulatory reporting agencies, Health Insurance Portability and Accountability Act (HIPAA), and Good Clinical Practice (GCP) standards
• Report any non-compliance to study investigator / departmental staff.
• Prepare any necessary materials for required internal and external (sponsor, FDA) regulatory and quality control audits and sponsor monitoring visits.
• Coordinate and schedule clinical trial monitoring visits
• May assist and collaborate with principal investigator and sub-principal investigators in clinic during patient appointments, consenting appointments and treatment appointments to ensure protocol is being adhered to and proper documentation is recorded.

Disseminate Clinical Research Information to Program:

• Navigate interdepartmental processes and relationships to ensure compliant study implementation.
• In collaboration with Regulatory Team:
  
  • Distribute clinical research related information to appropriate research team / affiliated institutional personnel as applicable.
  • Notify research team and those individuals directly involved in in pertinent areas of clinical research of protocol amendments, revisions, activations, closures and announcements.
  • Keep local Principal Investigator up to date on key information as related to the clinical research. Schedule and maintain records on appropriate trainings/meetings as needed.

Institutional Review Board (IRB) Compliance:

• Work with regulatory management team to adhere to regulations at OHSU for initial and continuing regulatory approval of clinical protocols such as annual re-approval/continuing review, amendment approval; and submission of reportable information.
• May perform regulatory documentation or creation of documents, as needed. Documents may include consent forms, IRB forms, and any necessary IRB documentation.

Design and Analysis:

• Assist Principal Investigators with the preparation of abstracts, grant
  applications and publications.
• Work with investigators to design experimental methods and/or operationalize the plan of clinical research projects to achieve protocol objectives.
• Communicate effectively across multiple clinical teams for clinical trial coordination.

Education:

• Participate in continuing education activities within the research program and other areas to maintain current knowledge of oncology disease process, research regulatory requirements, and process improvements for clinical trials.
• May assist with or lead training of junior team members.

Financial Responsibilities:

• Ensure correct ordering of procedures in compliance with the approved billing schedule.
• Verify that procedures/services are billed in accordance with the approved billing schedule.
• Collaborate with study team on financial planning and budget negotiation, as appropriate.

Additional duties: Additional duties as assigned by Clinical Research Manager


Required Qualifications

• Master's Degree in relevant field AND 3 years of clinical research coordination experience OR
• Bachelor's Degree in relevant field AND 5 years of clinical research coordination experience
• SoCRA or ACRP required within 12 months of hire
• Ability to prioritize multiple tasks at one time
• 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
• Proficiency with computers running Windows and PC applications e.g. MS Excel, Word and PowerPoint.
• Excellent customer service skills
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships

Preferred Qualifications

• Bachelor's degree with coursework in science or related field
• At least three years of direct clinical research experience
• Research experience with some knowledge of clinical trials
• Experience coordinating different phases of projects, including data collection
• Customer service experience
• Microsoft Office, Access, and other networking and database systems
• Medical terminology
• OHSU systems Oracle and/or Epic
• CCRP

Additional Details

Must be able to travel to all Knight worksite locations, including using the tram. Coordinator will work with human biological samples, including samples which may contain infectious disease. Coordinator will be expected to travel to conferences, new study meetings, and may travel for study monitoring at other sites. Position will require occassional weekend work and ability to focus in a busy cubicle environment with multiple

Why apply to OHSU?

We are Oregon's only public academic health center.

In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.

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 View email address on click.appcast.io