Sr Clinical Research Data Spec
Core
Provides high-quality data management support for complex clinical trials, ensuring accurate data reporting, compliance with protocols, and coordination with investigational faculty and sponsors.
Role type
Senior Clinical Research Data Specialist (IC)
Builds
Clinical trial data sets, status reports, and safety profiles for regulatory and sponsor submission
Domain
Healthcare / Clinical Research
Required skills
Data management, protocol adherence, regulatory compliance (GCP/GDP), data quality assurance, source data verification, adverse event reporting, study binder management, MS Office proficiency
Preferred skills
CCRC or CCRP certification, medical research terminology knowledge, UR-specific research software proficiency
Responsibilities
Coordinate with investigational faculty and sponsors to resolve data inquiries; formulate and organize data entry plans; conduct quality checks of data accuracy against source records; review medical records for prospective trial patients; prepare data status reports and drug safety profiles; assist in audit preparation and monitor visit readiness; maintain study binders and filings; update data in OnCore; mentor lower-level staff on data coordination tasks.
Seniority
Senior, hands-on IC
