Job Description: Oregon Health & Science University
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.
TI Clinical Research Assistant
US-OR-Portland
Job ID: 2024-31772 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Waterfront)
Overview
Contributes to feasibility assessment and research protocol management. Ensures research protocol implementation. 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.
These responsibilities include assisting with components of the IRB submission, to include preparation of consent forms and other documents required for IRB review. On-study duties include the coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be subject safety and compliance with the prescribed protocol and Good Clinical Practice. The TI Sr. CRA will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities. The CRC will maintain accurate, complete and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms. The TI Sr. CRA will ensure that patient billing is accurate and assist manager and financial team in verifying appropriate clinical trial billing for very complex oncology trials. This requires the TI Sr. CRA to have a solid understanding of the study financial lifecycle and how their work directly impacts this. The TI Sr. CRA may have direct patient contact, process biological samples and may perform other non invasive testing such as ECGs. The study coordinator will also assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.
The TI Sr. CRA will represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The CRC will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. Additionally, the TI Sr. CRA is required to learn and remain up to date on the oncology disease sites their team manages. This includes understanding the basic disease processes and current standard of care therapies used for each disease site. The TI Sr. CRA must be able to apply this knowledge to the tasks they are assigned.
Given the complexities of oncology research and the challenges of working with a terminally ill population, strong customer service, organizational, and interpersonal skills are required. Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time is necessary. Attention to detail, service orientation, delegation and project management skills, and above average critical judgment skills are essential.
* 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.
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.
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 medical record 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
Assist CRC expert or specialist in resolving clinic operations issues
Field research patient calls to the personnel most appropriately trained to address their questions/needs
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 medical record 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
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 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.
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.
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 trial. 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 assist or participate in regulatory documentation or creation of documents, as needed.
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.
Additional duties- Additional duties as assigned by Clinical Research Manager
Responsibilities
Education & experience:
Associate's AND 3 years of relevant experience OR
4 years of relevant experience OR
Equivalent combination of training and experience.
Knowledge, skills, and abilities:
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.
Intermediate skills with Microsoft Office (Excel, Outlook, Access, Word, and PowerPoint) on Window OS.
Must have demonstrated excellent customer service skills both on the phone and in person.
Must possess energy and drive to coordinate multiple projects simultaneously.
Ability to use tact and diplomacy to maintain effective working relationships
Qualifications
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/or other networking and database systems
