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University of Rochester Info Analyst II - 224990 in Rochester, New York

Info Analyst II Job ID 224990

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 052 CCRC

Schedule

8:30 AM-5 PM

Responsibilities

General Purpose:

To coordinate and implement clinical data acquisition and data operation activities for large multicenter NIH and corporate-sponsored international clinical trials studies including analyzing and interpreting data, disseminating study information to study physicians/coordinators, maintaining quality control of data in database based on high level of judgement to interpret operations and study protocol.

Formulates strategies, goals and information gathering methods. Plan, develop and implement protocols and instruments for data collection and data management. Suggests changes to information gathering methods. Advises sites on proper way to do procedures and recommends revisions to operations based on site feedback.

Specific Responsibilities:

Plans, coordinates, develops and implements processes for data collection including extraction and mapping data from test data media and analysis reports, source documents, and test procedure reports with subsequent entry of collected data using various electronic data capture systems/databases. Requires strong attention to detail and judgment based on high level interpretation of standard operating procedures and study protocol and application of principal concepts contained in these documents. Suggests changes to data collection processes based on media and source document review.

Reconciles data discrepancies as determined by existing computer programs, by verifying data from source documents and updating database accordingly, and assists with development of procedures for data quality control. Recommends revisions to operations based on site feedback. Implements strategies to address site concerns and trouble shoot data entry, queries, study data and database questions

Manages and recommends updates of data forms/operations manual based on feedback from sites, business analysts and IT programming working closely with managers and PI in planning ongoing information collection and study logistics, participating in study team meetings, and preparing progress reports.

Corresponds in writing and by phone with enrolling site personnel to obtain information for completing study data and resolving discrepancies. Includes weekly correspondence with sponsors on QA and study data issues. All correspondence is based on strong knowledge of the protocol and study operations to achieve the goal of data collection congruity across all enrolling sites. Recommends revisions to operations based on site feedback. Implements strategies to address site concerns and trouble shoot data entry, queries, study data and database questions. Advises sites on proper way to do procedures and recommends revisions to operations based on site feedback. Implements strategies to address site concerns and trouble shoot data entry, queries, study data and database questions.

Develops and manages archives of data media, event source documents, regulatory and correspondence documents with detailed tracking and appropriate document renewal to meet regulatory requirements involving both manual and electronic storage as well as creation of file management systems based on FDA compliance regulations. Recommends and documents ways to improve efficiency of document management process.

Develops spreadsheets and utilizes reports for error checking and tracking data in order to maintain strict consistent quality control procedures.

Assists with coordination of enrolling site training meetings and on line study training sessions for research study personnel at all member institutions while incorporating study protocol and study operational procedures to maintain congruent data collection processes across a large network of enrolling sites.

Maintains a good working knowledge of the cardiovascular research literature and FDA compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors.

Requirements:

Bachelor’s degree with appropriate health, social science, or biological science field and some graduate level course work in one of these fields; and 1-2 years experience in the analysis and dissemination of information; or equivalent of combination of education and related experience. Strong written and phone communication skills with ability to make independent decisions and attention to detail highly preferred. Experience with industry sponsored clinical trials preferred but not required. Proficiency in MS Word and Excel highly preferred.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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