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 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

The OHSU Knight Cancer Institute Clinical Research Assistant 2 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. Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time are necessary. Requires supervision; innovation and problem solving required; adaptability and a commitment to overall data integrity with ability to communicate and advocate for data quality.

 

The CRA2 will be expected to obtain and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern oncology clinical research. Additionally, the CRA2 is required to learn the basics about the oncology diseases that their team manages and know how to apply this knowledge to the tasks they manage. The CRA2 is also required to have a basic understanding of the study financial lifecycle and how their work directly impacts this.

 

 

Under general supervision, coordinates complex therapeutic interventional clinical research protocols and data management.

 

Key Responsiblites:

• Collection and entry of oncology data from patient electronic medical records and oncology research subject charts into oncology study databases, internal trackers (eCRIS), and Case Report Forms and upload patient imaging.  Maintenance of oncology research subject charts.
• Coordination study drug ordering and delivery from pharmacy to patient/study team.
• Assist study coordinators in assessing sample collection requirements and assembling study kits.
• Basic and complex sample management: collection, processing and shipping Assist study team with patient visits, including but not limited to:
  • May have direct patient contact to obtain or verify information and working with study team to triage clinical information and patient questions. May work with the study team and clinic to conduct timely blood draws (PKs), ECGs, vitals (blood pressure, temp, respirations, height, weight), wearable data tracking device management or other study-related procedures. Procure and process human biological specimens (including but not limited to blood, urine, feces, sputum, tissue). May facilitate patient’s completing and Patient Reported Outcome (PRO) questionnaires via paper forms, electronic tablets or verbal discussion and recording.
• Assist in the consenting process for observational studies and/or the pre-screening portion of an interventional trial.
• 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. Collaborate with study representatives to maintain data integrity including advocating for if/when data should not be changed. 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. This is to occur both in preparation for the monitor/audit visit and serving as a representative to support the monitor/auditor’s ability to access our site’s information.
• Participate in any disease and study team meetings, as required by the clinical research manager.

Education & experience:

• Bachelor's in relevant field OR
• Associate's AND
• 2 years of relevant experience OR
• 3 years of relevant experience OR
• Equivalent combination of training and experience

 

Knowledge, skills, and abilities:

• Ability to prioritize 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, Word and PowerPoint
• Excellent customer service skills
• Ability to work with a variety of diverse individuals and personalities
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships

Education & experience:

• Bachelor's degree with coursework in Science
• At least one year general office experience
• Clinical research experience
• 1-2 years of direct clinical trials experience
• Research experience 
• Experience coordinating different phases of projects, including data collection
• Customer service experience

Job Related Knowledge & Skills:

• Microsoft Office, Access, and/or other networking and database systems
• Medical terminology
• OHSU systems such as Oracle and/or Epic

Apply online. Please be sure to upload a Cover Letter and Resume/CV.

 

We offer a variety of benefits on top of joining a thriving organization:

• Medical, dental and vision coverage at no or low cost to employees
  • Covered 100% for full-time employees and 88% for dependents
• Several retirement plans to choose from with contributions from OHSU
• 25 days a year of paid time off
• 8 days of sick time off
• Commuter subsidies
• Tuition reimbursement
• Access to group life insurance, disability insurance and other supplemental benefits
• Annual Merit Increase
• Growth/Development Opportunities
• Employee discounts to local and major businesses

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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.