Research Data Coordinator Job Listing at MedStar Health in Washington, DC (Job ID 159332)

Description

About the Job

General Summary of Position
Under general direction of the Manager performs data collection entry reporting and verification. Participates in data analysis for research projects databases and research protocols conducted through MedStar Health Research Institute (MHRI). The Research Data Coordinator ensures highest data quality and integrity for all stages of data collection for a portfolio of trials assigned adhering to all applicable standards Good Clinical Practice (GCP) and FDA human subject protection regulations and hospital policies for conducting clinical research and collecting data into databases.

Primary Duties and Responsibilities

• Collaborates with research staff to design appropriate data collection tools (e.g. human subject calendars schedules tracking logs) to ensure collection is performed effectively within established timeframes and in compliance with GCP. Understands data management standards required and recommend changes/additions to established data fields as applicable.
• Collaborates with research staff to prepare/generate reports on the progress of the research project database or protocol on an as-needed or regularly occurring basis (i.e. weekly monthly quarterly). Compiles data and assists in consolidating/analyzing data for presentations and/or publications. Respond to follow-up requests as needed.
• Completes accurate data entry into the relevant data collection form as established by protocol program and project timelines once source documentation is ready. This timeline should not exceed 30 days after human subject visit. Ready for project monitor visits. Completes all data queries within the timeframe preferred and/or required by sponsor. Ensures accuracy and completeness of information (both electronic and paper forms).
• Demonstrates good judgment to make decisions and manage schedule to ensure that accurate work is accomplished within the required time points. Utilizes critical thinking to collect analyze and evaluate all relevant information prior to taking action. Prioritizes tasks and activities and communicates as appropriate with sponsor and/or study collaborators. Attends training for electronic data capture requirements for all protocols and data projects assigned.
• Identifies and performs broad screening for potential study/ program participants. Verifies participant eligibility according to protocol/ program specific criteria.
• Maintains awareness and possesses working knowledge of applicable federal states local and other regulations in the conduct of research work to ensure the highest quality research activities from site selection through study closure.
• Performs regular data verification checks to ensure that the data collected is complete and accurate (e.g. without typographical errors data compiled is clear calculations are accurate) meets sponsor/regulatory requirements and consistent with research project database or protocol and with source documentation.
• Utilizes appropriate methodologies to abstract and collect human subject information from source medical records (e.g. laboratory or diagnostic test results treatments delivered adverse drug reactions etc.) for a research project's databases, protocols, and/or programs.
• May function as a liaison between other MedStar locations and/or departments in relation to data-specific matters.

Minimal Qualifications
Education

• health science related degree, database background, or equivalent work experience required
• One year of relevant education may be substituted for one year of required work experience.

Experience

• 3 months to 1 year of clinical research work in the areas of data coordination and management for clinical trial participants-based on location preferred
• One year of relevant professional-level work experience may be substituted for one year of required education.

Knowledge Skills and Abilities

• Strong electronic data capture skills.