Description
The National Heart, Lung, and Blood Institute (NHLBI) is seeking information from small businesses regarding their capabilities to provide comprehensive data management support to the Division of Intramural Research (DIR) clinical research program. The program requires a team of 20 full-time Clinical Data Managers (CDMs) to work on specific protocols, research areas, and/or research teams. The CDMs will be responsible for research data-related activities, quality assurance/quality control, and database-related activities. The contract is expected to be for a period of one base year and four option years, for a total of five years.
Key aspects of the project include:
• Providing comprehensive data management support to the DIR clinical research program
• Employing a team of 20 full-time CDMs to meet the data management needs of the DIR's clinical research teams
• Performing research data-related activities, such as gathering and entering protocol data into databases
• Developing and structuring protocol-specific data management processes
• Abstracting and grading Adverse Events
• Running scheduled and ad-hoc reports for Research Teams
• Preparing data/reports for routine audits from clinical research monitors
• Participating in the reconciliation of data discrepancies identified in monitoring visits and audits