TI Clinical Research Associate

Oregon Health & Science University; Portland (OR); On-site; USD 70,000 - 100,000; Full time

Job summary

Oregon Health & Science University is seeking a Float Clinical Research Associate (CRA) to support the Knight Cancer Clinical Research organization. The role provides relief and interim support across programs, ensuring adherence to protocols, regulatory standards, and patient safety in translational oncology studies.

The Float CRA collaborates with physicians, nurses, and staff to coordinate study activities, manage documentation, and assist with regulatory tasks during staffing transitions or

Responsibilities

• Coordinate aspects of oncology clinical trials from startup to closeout in accordance with NCI/FDA guidelines.
• Prepare source documentation and maintain accurate records for research subjects.
• Ensure patient safety and protocol compliance, and support site visits/audits as needed.

Job description

Department Overview

The mission of the Knight Cancer Clinical Research 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 intense research environment requires complex clinical research studies involving a very vulnerable and sick population.

Department Overview

The mission of the Knight Cancer Clinical Research 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 intense research environment requires complex clinical research studies involving a vulnerable patient population.

Function/Duties of Position

This posting represents two (2) vacancies for the same type of role.

Position Summary

This TI Clinical Research Associate will be known internally as a Float Clinical Research Associate (Float CRA). It is a collaborative role supporting clinical research programs of the Knight Cancer Clinical Research organization. The Float CRA will 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 intense research environment requires management of complex clinical research studies involving a vulnerable patient population. The position will work with different programs within the Knight Cancer Clinical Research operation. They will provide relief, backup, or interim support to maintain progress on critical projects when there are staffing transitions or increased volume. Under occasional supervision, the Float CRA will perform a broad variety of tasks necessary for implementation and overall management of complex *therapeutic interventional clinical research. Specific tasks and roles will be determined by the needs of the clinical research program with which the Float CRA is engaged. These responsibilities will include the coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be patient safety and compliance with the prescribed protocol and Good Clinical Practice. The Float CRA will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities. The Float CRA will maintain accurate, complete, and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms. The Float CRA may have direct patient contact, process biological samples and may perform other non invasive testing such as ECGs. The Float CRA may represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The successful Float CRA will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. 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. The 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 Definition

• 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 Clinical Research Associate, represented by the Research Workers United (RWU), subject to the active collective bargaining agreement between OHSU and RWU.

Duties & Resonsibilities

Study Coordination

Responsibilities

Responsible for coordinating 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:

• Communicate effective across multiple clinical teams for clinical trial coordination. Be able to navigate and understand complex oncology clinical trial protocols
• 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’ medical record or paper source
• Communicate with the PI or Sub-I during patient visits regarding dose modification parameters
• Serve as the point of contact for the clinical staff to provide protocol guidance for patient management on trial
• Triage research patient communications to the personnel most appropriately trained to address their questions/needs
• Place research lab and procedure orders in compliance with the approved billing schedule.
• Review patient records to screen for potential trials
• Remove 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.
• Perform and document drug accountability.
• Prepare for upcoming visits including reviewing patient records to look for newly reported adverse events, concomitant medications, 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
• Review patient records to determine eligibility for enrollment into clinical trials. Confirm with the 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.
• Verify that procedures/services are billed in accordance with the approved billing schedule.
• Submit Invoices for tasks related to their role.
• Review and report adverse events or Unanticipated Problems to IRB and the study sponsor.
• Obtain vital signs and/or ECG measurements for study patients; conduct protocol-required tests such as the sit-to-stand test or walk test documenting contacts with study subjects as appropriate.
• Procure, process, and ship human biological specimens (including but not limited to blood, urine, feces, sputum, tissue) in adherence with protocol parameters and appropriate training.
• Communicate and faciliti…
• 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.

Data Management

• Collection and entry of oncology data from patient medical records into study databases
• Internal tracking and reporting
• Obtaining and uploading imaging
• Collaborate with study team to resolve data queries within deadlines
• Work with study team to correct any quality control issues
• Collaborate with study representatives to maintain data integrity
• Lab grading
• Obtaining study team signatures
• Scheduling and conducting study monitoring visits
• Collaborate with the study team to resolve any oncology data queries identified by the