Clinical Research Informatics Specialist - Associate

UT Health San Antonio•San Antonio, TX

12h

About The Position

Under direct supervision, performs data management tasks for studies using primarily traditional form-based data capture. Manages timeline; identifies and escalates risk.

Requirements

Ability to work in a diverse team environment
Strong verbal and written communication skills. and public speaking ability.
Possess strong attention to detail and a penchant for quality workmanship.
Strong personal computer skills with working knowledge of Microsoft Office products
Ability to work in a multi-tasked matrixed environment
Basic knowledge, skills and abilities with data management tools and methodologies.
Self-motivated and result oriented; takes ownership for deliverables and deadlines.
EDUCATION: Bachelors degree in a health profession is required.
EXPERIENCE: Three (3) years of related work experience is required.
LICENSES & CERTIFICATIONS: Clinical Data Manager (Required within 1 year of hire).
The Association for Clinical Research Professionals (Required within 1 year of hire).

Responsibilities

Create data and workflow diagrams based on written procedures, study protocols, interviews, observations, and expert knowledge.
Design and maintain study specific forms including form completion instructions and medical record abstraction guidelines.
Create logical data models based on study protocols, data dictionaries, forms, documents, and expert knowledge.
Draft and ensure up-to-date and accurate Data Management Plans (DMPs) including data definition, data models, data access and control procedures, study-specific procedures for all operations performed on data, study management reports, data quality control procedures, audit findings and corrective action responses.
Respond to internal and external audits by suggesting corrective action where necessary.
Provide leadership, day-to-day direction, support, and project coordination for Research Data Coordinators on project teams.
Serve as the primary point of contact for the UT Health research team for Informatics aspects of clinical studies; regularly interact with Sponsor representatives.
Maintain the scope of work throughout the project.
Draft and maintain deliverables, deliverable tasks, and timelines in the Project Management System for projects.
Manage data processing and other informatics operations on clinical studies.
Design and use study reports to manage aspects of studies and support overall management of clinical studies.
Provide regular and quantitative progress reports on system development, testing and implementation
Ensure identification, documentation and appropriate communication and handling of unplanned data-related problems and risk arising during a study.
Monitor and control data accuracy and completeness.
Hold regular team meetings to communicate project information and manage work on studies.