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Job Summary
General Summary/Overview Statement:
The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol. The CRDS I will be responsible for entering data for multiple oncology clinical trials. The CRDS I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.
Principal Duties and Responsibilities:
The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager:
· Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker
· Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements
· Proactively take steps to obtain missing source documents from all relevant sources
· Identify inaccurate source documents and track source document inconsistencies until resolved.
· Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems.
· Ensure appropriate documentation of own study-specific delegation and training prior to entering data.
· Ensure adequate source documentation is in place prior to entering data.
· Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.
· Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations
· Independently manage tumor response data entry
· Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies
· Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies
· Enter all required correlative research blood samples and clinical safety laboratory speci