Coordinator III - Research Data

Responsibilities

• Coordination management of complex protocols (multi-arm, multi-disciplinary, etc.)
• Creation and review of source documents
• Data collection, data entry, query resolution, triggering financial payments
• Study startup/close out
• Verifying, organizing, recording data in case report forms, CRF tracking, reviewing validation, updating, SAE reconciliation, reconciliation, query resolution and recording clinical information and data in case report forms
• Enters, validates, and audits clinical research data across electronic data capture systems
• Absorbs subject follow-up for clinical protocols and documents/report clinical study progress to assigned study team
• Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements
• Conducts protocol administration quality control monitoring, enforcement and database maintenance coding
• Conducts protocol administration quality control monitoring and enforcement
• May be responsible for database maintenance
• Acts as the liaison with the sponsor/CRO
• Aids in creation & implementation of tools to continuously improve team’s performance
• Communicates department’s measurable improvements & positive trends to management
• Aids in team guidelines adherence to timely preparation of study documents, data entry, and data locks
• Precepting and training on new systems and programs applicable to study coordination for research staff, including but not limited to coordination team, research nurses, infusion nurses, program managers, and regulatory affairs personnel
• Tracking and reporting of weekly workload & progress
• Aids in development and implementation of departmental operating procedures
• Represents coordination team in budget development related meetings
• Might assist in the creation of business development proposals by supplying coordination related information and costs
• Maintains communication flow in regard to study budget agreements, and budget amendments through the term of the project
• Collecting, organizing, and reviewing data as well as the development of data points for IIT trials
• Aids in conducting monthly quality checks of recorded data, verification of proper documentation, deviations, and compliance with timelines
• Aids in 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 observations and feedback on IIT data at various study timepoints
• Provides assistance to peers to ensure that study deadlines are met (data entry, query resolution, source document creation, review of study start up materials)

Qualifications

• Bachelor's or 4 years' work related experience in Health Science
• Knowledge of ICH/GCP, FDA regulations for clinical trials
• Excellent written and verbal communication skills
• Proficiency in MS Word, outlook, PowerPoint, Excel, EDC (electronic data capture)