This Clinical Research Data Coordinator position entails a high volume of data abstraction; no patient contact. The focus of this position is Oncology Clinical Trials. At least 1 year of previous clinical research data entry experience is required.
As a direct report to the Clinical Research Project Manager, this experienced Clinical Research Coordinator will assist the Cell Therapy Research Team with the demanding data requirements of our actively enrolling clinical research studies.
This Part-Time Clinical Research Coordinator assists with the following for multiple studies:
' Collects and interprets data necessary for enrollment; registers patients
' Monitors and evaluates protocol compliance
' Manages data collection via chart abstraction in EPIC and submits data in timely fashion
' Creates Research Charts and maintains to ensure audit readiness
' Creates Adverse Event Logs for Investigator review and sign-off
' Monitors and reports adverse events as required by institutional/federal regulations
' Resolves data discrepancies and queries as requested by Sponsors
' Requests and submits tissue samples as required by protocol
' Prepares submission of protocol revisions and safety reports to the IRB
' Prepares annual progress reports for IRB renewal of ongoing studies
' Participates in monitoring visits and makes data corrections as required by Monitor
This is a 20-24 hour/week position. The majority of the hours will occur between 9am and 4pm, though the schedule within these hours may fluctuate.
BA BS Required
Minimum of 1 Year Clinical Research Experience Requried
Massachusetts General Hospital