Lead Data Analyst​/EDC System Administrator Clinical Research Informatics

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.

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/activities as needed for coverage purposes,…