TI Sr Clinical Research Assistant

Department Overview

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable.

 

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

 

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

Function/Duties of Position

The OHSU Knight Cancer Institute Clinical Research Coordinator is responsible for implementation and overall management of oncology clinical trials.

 

Under minimal supervision, coordinate complex therapeutic interventional clinical research protocols..

 

 

 On-study duties include the coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be on the subject safety and compliance with the prescribed protocol and Good Clinical Practice. The CRC will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities.  The CRC 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.

 

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 a time is necessary.  Attention to detail, service orientation, delegation and project management skills, and above average critical judgment skills are essential.

 

 Key Responsibilities:

• Be able to navigate complex oncology clinical trial protocols that can be upwards of a 670 page document.
• Assist the PI or Sub-I with the informed consent process
• Assist the PI or Sub-I with the collection and documentation
• Work with Epic to place research lab and procedure orders
• Review patient records to screen for potential trials
• Communicate and facilitate oncology trial guidelines, timelines, and patient specifics withResearch Pharmacy, Clinics and various service departments to coordinate treatment for study patient.
• 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.

 

Work with the 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.

Communicate effectively  across multiple clinical teams for clinical trial coordination.

 

On-going Education-

Participate in continuing education activities within the research program and other areas to maintain current knowledge of oncology disease processes, research regulatory requirements, and process improvements for clinical trials.

Required Qualifications

Education & experience:

• Bachelor's Degree in relevant field AND 1 year of relevant experience OR
• Associate's AND 3 years of relevant experience OR
• 4 years of relevant experience OR
• Equivalent combination of training and experience.