Clinical Research Data Specialist I

Principal Duties And Responsibilities

• 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 specimen results into study-specific electronic data-capture system independently as required for individual studies
• Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies
• Work professionally with sponsor representatives to review and correct data recorded in the case report forms
• Track and appropriately manage sponsor data entry deadlines
• Resolve and answer data queries with minimal errors
• Perform standard data management quality control steps
• Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly
• Remain flexible and adapt to change and variety on the job
• Effectively handle unexpected situations and changing research subject and protocol conditions
• Develop individual research visit flow charts, intake sheets, and other tools as needed to independently ensure timely and accurate data entry

Skills/Abilities/Competencies Required

• Careful attention to detail
• Good organizational skills
• Ability to follow directions
• Good communication skills
• Computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects’ rights and individual needs