Description

Lead Data Analyst / EDC System Administrator for Clinical Research Informatics

US-OR-Portland

Requisition ID: 2026-37577
Position Category: Research
Job Type: Research
Position Type: Regular Full-Time
Posting Department: Knight Cancer Institute, Clinical Research Quality & Administration (CRQA)
Posting Salary Range: $67,454.40 - $107,764.80 per year with offer based on education, experience, and internal equity.
Posting FTE: 1.00
HR Mission: School of Medicine
Drug Testable: Yes

Department Overview

The mission of Knight Clinical Research Quality & Administration (CRQA) is to foster a supportive environment conducive to achieving the Knight's clinical research mission. CRQA provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.

Function/Duties of Position

OHSU Research classification:

Research Data Analyst 3

 

Position Summary:

The Lead Data Analyst / EDC System Administrator for Clinical Research Informatics supports a variety of clinical research informatics initiatives, including but not limited to, development of trial-specific electronic data capture (EDC) applications, Cancer Center Support Grant (CCSG) reporting, quality control (QC) and reporting efforts across oncology-related clinical research data, and data governance activities. Under occasional supervision, this individual applies extensive knowledge as a research professional with an in-depth understanding of statistical and/or other analysis techniques designed to support research projects of broad scope and complexity. Functions as a team lead, with a focus on the EDC program and EDC system administration. Provides consultation to investigators and research staff to develop and evaluate instruments, tools and training. Designs, coordinates and executes research projects of broad complexity and impact. Develops database tool(s) for tracking research and program data and assists in transmission and presentation of data. Compiles and interprets data. Contributes to formulation and prioritization of workflows and projects based on data. Helps train, guide and mentor project team members and/or other informatics staff.

 

As part of CRQA, this individual participates in formal and informal training relative to the position responsibilities described herein. Through the course of fulfilling the responsibilities of this position, this individual will also identify and actively propose revisions to educational materials, toolkits and SOPs to ensure consistency in messaging related to processes, regulatory compliance and research integrity. This individual independently manages workload within Knight/CRQA service level understanding timelines and job description expectations.

 

Duties & Responsibilities:

• EDC Application Builds:
  • Oversees and directly supports the development, construction and maintenance of trial-specific electronic data capture (EDC) applications for OHSU investigators conducting cancer-related clinical research within established Knight approved systems [e.g. Advarra, REDCap].
  • Serves as a subject matter expert (SME) for EDC systems and provides guidance to stakeholders on best practices related to data management.
  • Maintains project management tracking for EDC build projects in support of program metrics and to ensure clear communication to impacted stakeholders.
• EDC Application System Administration and Team Lead:
  • Oversees and directly contributes to EDC system administration and maintenance. For example, conducts routine SOP reviews and updates, risk assessments associated with system upgrades, and leads the Change Team in evaluating and managing other necessary system changes.
  • Maintains User Management database for all EDC users in keeping with 21 CFR part 11 compliance.
  • Maintains Project Change Request database to ensure post live requests and revision timelines.
  • Assigns EDC build and/or program related tasks to other informatics staff in support of the above.

• Data Governance and Reporting:
  • Contributes to the maintenance of a system of data governance and reporting within the Knight Cancer Institute as it relates to electronic data capture for protocol-driven clinical research studies and data within the clinical trials management system (CTMS). A system of data governance provides access, standardization, and definitions around critical data needed for the Knight Cancer Institute and is vital to ensure consistency, accuracy and overall trust in the data compiled for reporting and publication purposes.
  • Leveraging data governance infrastructure, serves as a subject matter expert for the design and maintenance of reporting solutions to extract and present data to meet analytic requirements.

• Overall:
  • Independently manages workload within CRQA service level understanding timelines and job description expectations.
  • As a member of OHSU, the Knight Cancer Institute, and the CRQA team, this individual participates in and contributes to team meetings and huddles, Knight-wide meetings, inter-departmental collaborations, process improvement initiatives, mentorship, and professional development activities as applicable to the role.
  • This individual also stays 'up-to-date' on OHSU-wide updates, fulfills all OHSU requirements necessary for ongoing employment, and otherwise is welcome to engage in OHSU-wide initiatives, within reasonable limits.
  • This individual may also provide back-up support to other CRQA positions/activities as needed for coverage purposes, understanding this may mean a temporary shift in FTE distribution of duties.

Required Qualifications

Education & Experience:

PhD Degree OR

Master's Degree AND 4 years of relevant experience OR

Bachelor's Degree AND 6 years of relevant experience.

 

Relevant experience should include: 

• Direct bioinformatics, relational database, Electronic Data Capture (EDC) design/build, and/or clinical research coordination/management experience.
• Two years of direct experience using an Enterprise BI tool (e.g., Cognos, Tableau, Power BI) and/or direct experience designing/building clinical research related Electronic Data Capture (EDC) databases.

Knowledge, Skills & Abilities:

• Strong knowledge of clinical research and Good Clinical Practice (GCP).
• Strong knowledge of database/ data capture applications; i.e. design, construction, use and management.
• Strong knowledge of reporting functionality; i.e. requirements gathering, documentation, database query development, data table relationships, validation and management.
• Detail oriented while still seeing the "big picture," maintaining a solution-oriented approach to issues.
• Demonstrated excellent customer service skills that translate into timely and reliable service to PIs and staff.
• History of multiple successful research informatics projects with high user satisfaction.
• Demonstrated ability to work independently and as part of a team while being collaborative in resolving problems; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations; ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
• Excellent record of time management and setting appropriate priorities.
• Must possess the energy and drive to work on multiple projects simultaneously and see them through to completion.
• Demonstrated ability to manage QA plan and execute projects, organize and track data/metrics, collaborate with domain leadership and OHSU leadership.
• Demonstrated ability to solve problems, think critically and creatively and maintain flexibility in a changing/evolving work environment.
• Demonstrated excellent communication, analytical and organizational skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal convictions while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view, and to use tact and diplomacy to maintain effective working relationships.
• Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).
• Ability to accurately type 60wpm

Preferred Qualifications

• Degree in computer science, information technology, informatics/bioinformatics, healthcare/biological/life sciences, or Health IT/Informatics.
• Experience working in oncology or investigator-initiated clinical trials;
• Programming experience (e.g. C#, HTML);
• Experience in software application development, validation, execution, maintenance, documentation and/or data archival;
• Experience with EDC system design/build (e.g., Advarra EDC, REDCap);
• Experience using application reporting tools (e.g. Business Objects, Cognos, Tableau)
• Business analysis and/or project management terminology
• ACRP or SoCRA Certification (e.g. CCRC, CCRA, CCRP)
• Project Management and/or Business Analysis Certification or Accreditation

Additional Details

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
• 9 paid holidays
• 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

 

#linkedin #indeed #knightinternal #knightcancerjobs

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.

PI281685424