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 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.

 

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

This OHSU Knight Cancer Institute TI Sr. Clinical Research Assistant (TI Sr. CRA) is responsible for the collection, entry, and general management of oncology study data for oncology clinical trials.

Primary duties include ensuring accurate and complete research data is collected from oncology clinical trial study subjects and entered into the appropriate Case Report Forms. This role will also assist with the coordination of oncology clinical trial monitoring visits, data query resolution, and quality control of collected research data.

 

The successful candidate will have and maintain a working knowledge of oncology data, a vast variety of differing electronic database systems, and a working collaboration with our internal and external partnerships. Strong communication skills and attention to detail are required. The ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time is necessary. Requires general supervision; innovation and problem solving required; adaptability and a commitment to overall data integrity with ability to communicate and advocate for data quality.

 

Key Responsibilities:

• Collection and entry of oncology data from patient electronic medical records and oncology research subject charts into oncology study databases. Maintenance of oncology research subject charts.
• Collaborate with the study team to resolve any oncology data queries identified by the study monitor, auditor, or other individual reviewing the study data within tight deadlines with competing priorities. Work with the study team to correct any quality control issues with the data entry. Additional tasks may include but are not limited to: Lab grading, obtaining and verifying study team signatures/oversight.
• Assist the study team with the coordination of study monitor/auditor visits by scheduling and obtaining monitor/auditor access and assist the study monitor/auditor with any oncology data entry queries. Participate in any disease and study team meetings, as required by the clinical research manager.
• Provide support and periodic coverage to the study team, as delegated by the Clinical Research Manager. This includes, but is not limited to, safety report tracking and processing, assisting with patient visits and study assessments (processing/shipping lab samples, ECGs, vitals, specimen collection & management, etc), requesting medical records, and other study related tasks, as needed.

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.

Knowledge, skills, and abilities:

• High degree of attention to detail
• Ability to multi-task
• Ability to follow through and complete tasks
• Ability to track progress and update others on status of data collection
• 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.
• Proficient with computers running Windows and PC applications e.g. MS Exce