
Research Data Coordinator
- Phoenix, AZ
- $25.55-38.00 per hour
- Training
- Full-time
- Maintains a high-level of expertise and abstracts information independently from a wide range of data collection tools or the subject's medical record and enters required protocol data into the study-designated data collection system
- Ensures data is entered/reported in a timely manner keeping with clinical trial agreements and institutional standard operating procedures.
- Identifies data discrepancies and/or missing data and follows up with investigators and the study team to resolve.
- Reports data quality issues at study meetings and provides suggestions for ways to resolve the issue
- Reviews monitoring/audit reports database queries and resolve errors to ensure the integrity of data.
- Provides coverage for the team as appropriate.
- Responsible for reporting on each study including information related to protocol activity data monitoring/auditing and other research information; presents this information at regular research staff meetings.
- Ensure data compliance for ICH GCP and regulatory authorities.
- Develops methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency standards.
- May support the lead data management specialist in the development of the study database according to clinical trial specifications including: eCRF design user requirements edit check specifications user acceptance testing (UAT) medical coding query management data validation programming and testing data imports/exports.
- Ensure data system compliance for ICH GCP and regulatory authorities.
- May train others in work responsibilities.
- Collaborates with the investigator(s) study coordinator research nurse monitors and data manager regarding the protocol requirements.
- Collaborates with the study coordinator research nurse or research assistant to document and report study patient enrollment treatment and follow-up into the study database including protocol adherence adverse events and treatment outcomes.
- Assists with the coordination of organized meetings conference calls and training.
- Participates in site initiation interim monitoring and close-out visits internal audits and external audits/inspections.
- Attends and actively participates in regularly scheduled multidisciplinary tumor boards staff meetings disease site program research meetings and role-specific meetings.
- Participates in department-based process improvement or advisory groups.