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 as we know it, 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 require management of complex clinical research studies involving a very vulnerable and sick population.

Function/Duties of Position

This OHSU Knight Cancer Institute TI Sr. Clinical Research Assistant (TI Sr. CRA) is responsible for implementation and overall management of oncology clinical trials. Under minimal supervision, coordinates complex therapeutic interventional clinical research* protocols and data management.

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. This position will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities. This position will maintain accurate, complete and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms. This position 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. This position may have direct patient contact, process biological samples and may perform other non invasive testing such as ECGs. This position 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.

This position will represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. This position will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. Additionally, this position 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. This position must be able to apply this knowledge to the tasks they are assigned.

In addition to study coordination, this position will also be responsible for the following clinical actitivies, within the Scope of Practice relevant to Medical Assistant credentialing, as defined by OHSU, which may include but are not limited to: 

• Accept verbal and telephone orders from providers and act on these after performing a “read back”;
• Administer approved medications based on competency, including IM, SC or ID injections;
• Follow up telephone contact with patients following procedures, or investigational treatment, deferring to RN or LIP for questions or situations outside of scope;
• Assist with scheduling and beacon issues as they arise;
• Make initial contact with patient about potential eligibility for a clinical trial.

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.

Required Qualifications

Edcuation and experience:

Bachelor's Degree in relevant field and 1 year of relevant experience OR

Associate's and 3 years of relevant experience OR

No degree and 4 years of relevant experience OR

Equivalent combination of training and experience.

Medical Assistant certification required in addition to the above combination of experience.

Required competencies:

• High degree of attention to detail
• Ability to prioritize and complete 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, Oracle, Access, Word and PowerPoint)
• Demonstrated excellent customer service skills both on the phone and in person
• Possess energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships
• Critical Thinking skills
• Time management skills

Preferred Qualifications

• Experience as a Medical Assistant
• Clinical trial knowledge with a minimum of 1 year of research experience
• Experience conducting different phases of projects, including data collection and 3-5 years of clinical trial experience
• Networking and database systems
• Medical terminology
• Working knowledge of Epic
• CCRP or ACRP Certification
• Typing 40 wpm

All are welcome

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.