TI Clinical Research Associate

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.

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 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

 

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 effectively 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