Job Summary The Research Data Coordinator III is an experienced coordinator who demonstrates autonomy in the data management of complex protocols, mentoring of new research staff, and assisting in quality review and process improvement. This position supports our organization's efforts to achieve service excellence to our patients, investigators, and sponsors.
Responsible for data management of complex protocols (multi-arm, multi-disciplinary, etc.). May be the sole coordinator on studies, responsible for Screening, recruitment, obtaining informed consent, source documents, data collection, data entry, query resolution, triggering financial payments, study close out, and liaison with the sponsor/CRO.
Assists with creation & implementation of tools to continuously improve team's performance. Communicates department's measurable improvements & positive trends to management. Assists with team guidelines adherence to timely preparation of study documents, data entry, and data locks.
Assist with mentoring and training on new systems and programs applicable to data management for research staff, including research data coordinators, research nurses, infusion nurses, project managers, and regulatory affairs personnel.
Assists with tracking and reporting of team's work load & progress on a weekly basis. Assist in development and implementation of departmental operating procedures. Represents data management team in budget development related meetings. May assist in the creation of business development proposals by supplying data management related information and costs. Maintains communication flow in regards to study budget agreements, and budget amendments through the term of the project
Assists team's supervisor with conduct of monthly quality check of clinical data recorded and submitted on case report forms. This includes verification of proper documentation of clinical data, deviations and compliance with timeliness specified by sponsors.
Assists with identification & documentation of regulatory and protocol deviation findings. Analyzes findings and communicates potential solutions to management. Verification of proper reporting of events, including IRB reporting.
Provides assistance to peers to ensure that study deadlines are met, by being a backup on studies (data entry, query resolution, source document creation, review of study start up materials, Handles and labels samples and ships samples etc.). Performs other related duties as assigned.
Internal Number: 2019-15905
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