Job Description

Department Overview

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 therapeutic interventional (TI) trials and clinical research studies involving a very vulnerable and sick population.

Therapeutic Interventional (TI) 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, or Cell Therapies.

Function/Duties of Position

This Clinical Research Assistant-Data Manager is responsible for the collection, entry, and general management of oncology study data for oncology clinical trials.

OHSU classification Therapeutic Interventional (TI) Senior Clinical Research Assistant

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.

Responsibilities include:

• 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.
• 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.
• 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 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.

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

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.

Preferred Qualifications

• Clinical trial knowledge with a minimum of 1 year of research experience
• Prior data entry experience
• Oncology 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

Additional Details

Apply online. Please be sure to include a resume or CV and cover letter with your application.

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Why apply to OHSU?

We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington. All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu