Develops electronic representations of Case Report Forms (CRFs) and data survey/questionnaires, ensuring that electronic designs comply with normalized database design fundamentals. Creates database panels and data entry screens. Researches and suggests new methods for using database development tools. Creates and programs error specifications to ensure data quality. Creates and maintains documentation in support of tasks they perform. Generates ad hoc reports for end-users using system tools and database queries and scripts. Integrates data from variety of sources, including laboratory results, to produce requested or required data elements. Maintains and audits data, providing status and activity reports as required. Maintains databases, record keeping systems, and master files for protocols in conjunction with research staff.
Create annotated (e) Case Report Forms, build, test and maintain clinical databases, program and test automated edit checks.
Executes clinical database setup and data processing activities according to agreed standard and timelines.
Develops computer programs using various software packages and programming languages and/or performs the necessary manipulations to import complex external data or export output to other computer files.
Extracts data from specified databases as directed and creates data-sets for analysis.
Performs chart or similar reviews to extract data as directed.
Develops computer programs, using primarily SQL, to create derived data sets or performs another advanced data manipulation.
Assists with the development of advanced computer programs, using other software if necessary, to perform system tasks and macros/utilities to increase the quality and efficiency with which results are produced.
Ensures that programs are documented in accordance with Working Guidelines.
May be required to assist in other programming tasks using software other than SAS (e.g. SQL) to support or specialized study data requirements.
Prepares documents to describe computer programs and databases for large projects.
Performs group and departmental Quality Control (QC) procedures.
Reviews project request describing database user needs.
Studies existing data handling systems to evaluate effectiveness, and develops new systems to improve production or workflow as required.
Teaming and collaborating with the community to generate innovative designs and ensuring consistency.
Gathering user data using methods such as task analysis and participatory design, based on information from surveys, focus groups, and/or your user experience design and development.
Generating and maintaining specification documents- Working with data management to validate designed functionality.
Analyzing quantitative and qualitative data and presenting findings and recommendations to the team.
Assists with importing, cleaning, transforming, and validating data.
Assists in developing systems for organizing data to analyze, identify and report trends.
Analyzes data and defines logical aspects of data sets and shares information with research staff and management.
Works closely with colleagues to try and identify data related problems and solve them.
Develops and prepares information programs to be used by study staff.
Performs other duties as assigned.
Knowledge of clinical research process and methodology.
Knowledge of concepts, theories, practices and procedures of database programming and data analysis methodology.
Excellent quantitative and analytical skills.
Strong critical thinking and problem-solving skills;
Ability to think linearly and sequentially.
Demonstrated software and technical skills. Proficiency with analytical tools (MS SQL, MS Access).
Ability to write and execute MS SQL queries to extract data.
Ability to use advanced features of Excel, i.e. Formulas, Functions, Lookups.
Ability to analyze and interpret data, identify errors and prepare reports.
Ability to show initiative, good judgment, and resourcefulness.
Excellent oral and written communication skills.
Must be able to read, write, and speak fluent English.
Problem Solving & Impact:
Works on problems of diverse scope that requires analysis of data and identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Decisions made generally affect a work unit or area within a department.
Work is closely supervised. Follows specific, detailed instructions.
Provides recommendations and solutions to staff and management.
Typically reports to a Manager or Director.
Typically requires a minimum of 0 - 3 years of experience in database design and database programming for research programs.
Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
Programming experience (VBA, PHP, HTML, XML, SQL) preferred.
Work in a clinical, regulated environment (GCP, GLP, GMP) preferred
Programming experience in Clinical EDC systems (OpenClinica, REDCap, or other clinical data management systems) preferred.
Non-governmental organization (NGO) experience preferred.
Typical Physical Demands:
Typical office environment.
Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
Ability to sit and stand for extended periods of time.
Ability to lift 5 - 50 lbs.
Technology to be Used:
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
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FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.