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Kaiser Permanente Careers

Research & Development

Innovation in Practice

Operating one of the industry’s largest and most respected research programs, Kaiser Permanente employs nearly 1,800 research experts at 9 specialized centers across the country. With a research budget of $221 million and more than 2,500 studies and clinical trials underway at any given time, this is a place where you can have a profound impact on the future of health.

Coordinator, Clinical Trials Data

Location: Portland, OR Job Number: 936109 Date posted: 02/18/2021

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Description:
The position is accountable for carrying out a variety of data management and data collection activities for all types of clinical trials and clinical research projects in a manner which promotes accuracy, efficiency, and compliance with government regulations and KP policies. Uses a broad range of computer assisted technologies and interpersonal skills to meet project and department needs.

Essential Responsibilities:
  • Coordinate and support day-to-day departmental data management activities to assure both project and departmental goals are met. Using a variety of computer technologies--including HealthConnect--collect and record data related to human subject participation in clinical trials. Report and transmit data to appropriate study staff and departments according to protocol requirements and KPNW policies and procedures. Identify and abstract health conditions and document findings per study protocol. Develops own system(s) for tracking data submissions and deadlines so as to submit data in a timely manner. Coordinate and facilitate data requirements for non-KP sponsors and collaborators. Prepare and organize appropriate documents and study materials for all sponsor monitoring visits and audits. Performs data abstraction from Health Connect or other source documentation, completing data forms (electronic or paper) in an accurate and timely manner. Perform and coordinate tasks which link data collection processes such as: prepare and QC study charts, compile forms, assign labels and numbers, and monitor processes. Edits own work carefully; reviews and edits the work of others as assigned. Participates in quality assurance reviews and audits. Seeks consultation appropriately. Completes all required training and certification. Assists in tracking completion of training and certifications by other research providers (staff, PI, sub-investigators, etc.). Remains knowledgeable of all manuals, protocols and project procedures. Notifies appropriate team member when edits are required. Proficient use of various computer applications for data collection and management. Includes Windows, Excel, EPIC/HC and other Clinical Trial Management systems for generating, as well as recording information. Also includes certification in all sponsor-mandated electronic data systems for all clinical trials.
  • Interact with co-workers in ways that promote personal and professional growth in the work group. Work with Department Managers and supervisors to promote a partnering work environment through effectively communicating with Investigators, Project Managers, and other CHR/KP staff. Assist in training new staff to their data management roles and responsibilities within their position. Work to create a mutually supportive environment that reflects the goals of the department and CHR/KP. Actively participates in department quality management plan. Maintain regular contact with other KP regional data coordinators in order to share information and ideas. Perform other duties as requested.
  • Assure that quality data is collected, managed, used and disclosed in compliance with HIPAA and KP requirements. Collect and document accurate data on research participants following stringent guidelines regarding confidentiality and protection of human subjects. Apply thorough knowledge of GCP (Good Clinical Practices), Human Subject Committee and Federal Drug Administration rules and regulations that apply to human subject's research. Accurately completes forms; adheres to scripts and manuals of operations. Completes data entry in various departmental databases. Edits and transmits data to data analysts and coordinating centers, maintaining transmission records. Monitor, document, and report study issues. Identify problems and alert team members.
  • Assure customer satisfaction through an organized and seamless process. Collaborate effectively with other members of the study team. Thinks of ways to improve results and achieves excellence through continuous learning. Educate and backup other study team members. Suggest improvements to data collection procedures.
  • Basic Qualifications:
    Experience
  • Minimum two (2) years experience working in a clinical setting with at least one (1) year working directly patients.
  • Education
  • High School Diploma or General Education Development (GED) required.
  • License, Certification, Registration
  • N/A

  • Additional Requirements:
  • Experience in conducting clinical trial activities abiding by a study protocol.
  • Extensive knowledge of medical terminology, anatomy, disease processes and research data management regulations.
  • Extensive knowledge of medical records organization and interpretation.
  • Demonstrated aptitude to analytical thinking, attention to detail, organization and problem solving.
  • Demonstrated proficiency in using a computer and learning new technology.

  • Preferred Qualifications:
  • Minimum two (2) years experience leading or managing research data collection functions in a clinical setting.
  • Thorough knowledge and experience with multiple data collection techniques and data quality control in a research setting.
  • Thorough knowledge of GCP (Good Clinical Practices), Human Subject Committee and Federal Drug Administration rules and regulations.
  • Familiarity with classification of disease processes (diseases, symptoms, procedures, lab/xray tests, drugs, and episodic relationships).
  • Extensive experience using MS EXCEL, MS WORD, MS ACCESS to organize and communicate information.
  • Associate's degree or extensive college courses in social sciences or related field.
  • Primary Location: Oregon,Portland,Center for Health Research Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon - Fri Working Hours Start: 08:00 AM Working Hours End: 04:30 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: NUE-NW-01|NUE|Non Union Employee Job Level: Entry Level Job Category: Research and Development Department: Center for Health Research - Rsrch Mgmt-Clincl Trials Admin - 1001 Travel: No Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

    External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.

    Learn About Research & Development Careers

    Careers in Research & Development

    Recognized worldwide for their scientific expertise, our researchers collect data on topics including cardiovascular disease, diabetes, mental health, and drug safety — just to name a few.

    In addition to studies centered at these facilities, our physicians and researchers conduct clinical trials of new drugs, medical devices, and other therapies through several organized centers and independently at single sites. Put together, Kaiser Permanente's research centers and scientists comprise one of the largest and most comprehensive nonacademic research programs in the United States.

    As a member of this team, you'll engage in meaningful work that has the power to affect outcomes and improve global health. Focused on areas like public-sector health services, epidemiology, and behavioral and clinical research, the work you do will ultimately allow us to improve the cost effectiveness and quality of the care we deliver — all while saving lives.

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